Drug Information Update

Transcription

1 Drug Information Update July 2018 Page 0 of 113

2 TABLE OF CONTENTS NEWLY AVAILABLE GENERICS... 2 NEW DRUG ENTITIES/COMBINATIONS/STRENGTHS... 3 NEW INDICATIONS (EXISTING DRUGS)... 7 FDA NEWS/BULLETINS/ADVISORIES/SAFETY ALERTS... 8 STUDIES AND RECENT TOPICS RECALLS CURRENT DRUG SHORTAGES Page 1

3 NEWLY AVAILABLE GENERICS GENERIC DRUG NAME BUPRENORPHINE HCL/NALOXONE HCL STRENGTH & DOSAGE FORM GENERIC MANUFACTURER BRAND NAME 8mg-2mg DR. REDDY S LAB SUBOXONE ISOPROTERENOL HCL 0.2mg/mL CIPLA USA, INC. ISUPREL HYDROXYPROGESTERONE CAPROAT/PF 250 MG/ 1 ML VIAL AMER. REGENT PRASCO LABS MAKENA BUDESONIDE 9 MG ACTAVIS UCERIS KETOPROFEN COLESEVELAM HCL 25 MG 3.65 GRAM TEVA HERITAGE GLENMARK PHARMA KETOPROFEN COLESEVELAM HCL Page 2

4 NEW DRUG ENTITIES/COMBINATIONS/STRENGTHS DESCRIPTION BRAND NAME GENERIC NAME STRENGTH NOTES ANTINEOPLASTIC MEK1 AND MEK2 KINASE INHIBITORS MYDRIATICS ANTINEOPLASTIC BRAF KINASE INHIBITORS ANTINEOPLASTIC BRAF KINASE INHIBITORS INFLUENZA VIRUS VACCINES INFLUENZA VIRUS VACCINES INFLUENZA VIRUS VACCINES INFLUENZA VIRUS VACCINES INFLUENZA VIRUS VACCINES INFLUENZA VIRUS VACCINES INFLUENZA VIRUS VACCINES INFLUENZA VIRUS VACCINES INFLUENZA VIRUS VACCINES SEDATIVE-HYPNOTICS, NON-BARBITURATE ANTIPSYCHOTICS, ARTP, D2 PARTIAL AGONIST/5HT MIXED MEKTOVI BINIMETINIB 15 MG New entity TROPICAMIDE- CYCLOPENTOLATE- PE CYCLOPENTOLAT/ TROPIC/ PHENYLEPH 1%-1%-2.5% OPHTHALMIC New dosage form code BRAFTOVI ENCORAFENIB 50 MG New entity BRAFTOVI ENCORAFENIB 75 MG New entity FLUARIX QUAD FLULAVAL QUAD FLULAVAL QUAD FLUZONE QUAD FLUBLOK QUAD FLUZONE QUAD FLUZONE QUAD PEDI FLUZONE HIGH- DOSE FLUZONE QUAD MKO (MIDAZOLAM- KETAMINE-ONDAN) ARISTADA INITIO FLU VACC QS (6MOS UP)/PF FLU VACC QS (6MOS UP)/PF FLU VACC QUAD (6MOS UP) FLU VACC QUAD (6MOS UP) FLU VACC QV 2018 (18YR UP)RCM/PF FLU VACC QS MOS UP/PF FLU VACC QS 2018 (6-35 MOS UP)/PF FLU VACC TS (65YR UP)/PF FLU VACC QS MOS UP/PF MIDAZOLAM/ KETAMINE/ ONDANSETRON ARIPIPRAZOLE LAUROXIL 60 MCG/0.5 ML 60 MCG/0.5 ML 60 MCG/0.5 ML 60 MCG/0.5 ML 180 MCG/0.5 ML 60 MCG/0.5 ML 30 MCG/0.25 ML 180 MCG/0.5 ML 60 MCG/0.5 ML MG 675 MG/2.4 ML IM INJECTION New entity New entity New entity New entity New entity New entity New entity New entity New entity New combination New entity ANAGESICS, NARCOTICS ROXYBOND OXYCODONE HCL 15 MG New strength ANALGESICS, NARCOTICS ROXYBOND OXYCODONE HCL 30MG New strength Page 3

5 DESCRIPTION BRAND NAME GENERIC NAME STRENGTH NOTES FACTOR IX PREPARATIONS ERYTHROPOIESIS- STIMULATING AGENTS SICKLE CELL ANEMIA AGENTS GLUCOCORTICOIDS OPHTHALMIC ANTI- INFLAMMATORY IMMUNOMODULATOR- TYPE VAGINAL ESTROGEN FOR SEXUAL DYSFUNCTION VAGINAL ESTROGEN FOR SEXUAL DYSFUNCTION MIOTICS AND OTHER INTRAOCULAR PRESSURE REDUCERS MIOTICS AND OTHER INTRAOCULAR PRESSURE REDUCERS MIOTICS AND OTHER INTRAOCULAR PRESSURE REDUCERS MIOTICS AND OTHER INTRAOCULAR PRESSURE REDUCERS MIOTICS AND OTHER INTRAOCULAR PRESSURE REDUCERS MIOTICS AND OTHER INTRAOCULAR PRESSURE REDUCERS MIOTICS AND OTHER INTRAOCULAR PRESSURE REDUCERS IDELVION RETACRIT FACTOR IX RECOM, ALBUMIN FUSION EPOETIN ALFA EPBX 3500 (+/-) New strength 40,000/ML SIKLOS HYDROXYUREA 100 MG DEXONTO CYCLOSPORINE IN KLARITY DEXAMETHASONE SODIUM PHOSPHATE CYCLOSPORINE/ CHONDROIT SULFA % % IMVEXXY ESTRADIOL 10 MCG IMVEXXY ESTRADIOL 4 MCG LATANOPROST LATANOPROST/PF 0.005% BRIMONIDINE DORZOLAMIDE TIMOLOL DORZOLAMIDE LATANOPROST TIMOLOL DORZOLAMIDE TIMOLOL BRIMONIDIN DORZOLAMIDE TIMOLOL LATANOPROST TIMOLOL BRIMONI DORZOL LATANOP BRIMONIDINE/ DORZOLAMIDE/PF TIMOLOL/ DORZOLAMIDE/ LATANO/PF DORZOLAMIDE/ TIMOLOL/PF TIMOLOL/ BRIMONIDIN/ DORZOLAM/PF TIMOLOL MALEAE/ LATANOPROST/PF TIMOLO/BRIMON/ DORZO/LATANOP/ PF 0.15% - 2% 0.5% - 2% % 2% - 0.5% 0.5% % - 2% 0.5% % 0.5% % New strength New dosage form, new strength New dosage form New combination New dosage form New dosage form, new strength Preservative free New combination New combination Preservative free New combination New combination New combination Page 4

6 DESCRIPTION BRAND NAME GENERIC NAME STRENGTH NOTES MIOTICS AND OTHER INTRAOCULAR PRESSURE REDUCERS DORZOLAMIDE DORZOLAMIDE HCL/PF 0.02 Preservative free EYE ANTIBIOTIC AND GLUCOCORTICOID COMBINATIONS GATIFLOXACIN DEXAMETHASONE GATIFLOXACIN/ DEXAMETHASONE 0.5% - 0.1% New combination EYE ANTI- INFLAMMATORY AGENTS PREDNISOLONE ACETATE PREDNISOLONE ACETATE/PF 0.01 Preservative free JANUS KINASE (JAK) INHIBITORS XELJANZ TOFACITINIB CITRATE 10 MG New strength DRUGS TO TREAT ERECTILE DYSFUNCTION IFE-BIMIX 30/1 PAPAVERINE/ PHENTOLAMINE/ WATER 30-1 MG/ML INTRACAVER. New strength DRUGS TO TREAT ERECTILE DYSFUNCTION IFE-PG20 ALPROSTADIL IN SODIUM CHLORIDE 20 MCG/ML INTRACAVER. New strength LEUKOCYTE (WBC) STIMULANTS FULPHILA PREGFILGRASTIM JMDB 6 MG/0.6 ML SUB-Q New entity; Neupogen biosimilar NSAID AND TOPICAL IRRITANT COUNTER- IRRITANT COMB NUDROXIPAK I- 800 IBUPROFEN/CAPSAI /M- SAL/MENTHOL 800 MG % Rx and OTC in kit NSAIDS,COX-2 SEL.INHIB.(SYST)- TOP.IRRITANT CTR-IRR NUDROXIPAK IBUPROFEN/CAPSAI /M- SAL/MENTHOL 200MG-.025% Rx and OTC in kit ANTIRETROVIRAL- NUCLEOSIDE, NUCLEOTIDE, PROTEASE INH. SYMTUZA DARUNAVIR/COB/E MTRI/TENOF ALAF MG New Combination AMINOGLYCOSIDE ANTIBIOTICS ZEMDRI PLAZOMICIN SULFATE 500MG/10M L New Entity INFLUENZA VIRUS VACCINES AFLURIA FLU VACCINE TS (5 YR UP) 45MCG/.5ML New Entity INFLUENZA VIRUS VACCINES AFLURIA QUAD FLU VACC QUAD (5 YR UP) 60MCG/.5ML New Entity INFLUENZA VIRUS VACCINES AFLURIA QUAD FLU VACC QUAD 2018(5 YR UP)/PF 60MCG/.5ML New Entity INFLUENZA VIRUS VACCINES AFLURIA FLU VACCIN TS YR UP/PF 45MCG/.5ML New Entity Page 5

7 DESCRIPTION BRAND NAME GENERIC NAME STRENGTH NOTES INFLUENZA VIRUS VACCINES FLUAD FLU VACC TS2018(65UP)/MF5 9C/PF 45MCG/.5ML New Entity Page 6

8 NEW INDICATIONS (EXISTING DRUGS) None Page 7

9 FDA NEWS/BULLETINS/ADVISORIES/SAFETY ALERTS Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections [Posted 06/14/2018] ISSUE: At least 43 patients reported adverse events after receiving eye injections of Guardian s Pharmacy Services compounded triamcinolone-moxifloxacin product during cataract surgery. The patients reportedly experienced various symptoms, including vision impairment, poor night vision, loss of color perception, and significant reductions in best-corrected visual acuity and visual fields. FDA identified multiple substances in Guardian s product, including poloxamer 407 and poloxamer 407 degradants. FDA prepared in-house samples of Guardian s product and found that autoclaving and sonication caused the poloxamer 407 to degrade. The amount of poloxamer 407 in Guardian s product (12%, g/100 ml) is much greater than the maximum amount of poloxamers in FDA-approved ophthalmic products for topical administration ( %, g/100 ml), and the safety profile of drug products intended for intravitreal injection containing poloxamer 407 is unknown. BACKGROUND: As part of its investigation into these adverse events, FDA collected and tested samples of Guardian s product to identify and quantify the substances contained therein. FDA also prepared and tested in-house samples to assess the impact of autoclaving and sonication, which were used by Guardian during its compounding process, on the stability of the drug product. Below is a description of the test results and the agency s analysis of those results. RECOMMENDATION: Compounding pharmacies should determine, based on the route of administration and the organ or tissue involved, whether the excipients are safe in the amount that will be present in the administered dose. One way to accomplish this is to use an excipient in an amount where scientific data support its safety, such as data supporting FDA approval of a comparable drug product with a similar concentration of the excipient. Compounding pharmacies also should consider whether the compounding process will generate degradants of such ingredients. Because compounded products are not evaluated by FDA for safety, effectiveness, or quality, health professionals should consult the compounding pharmacy about the safety information related to the excipients in the compounded products they plan to inject into their patients. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report Online: Download form or call to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to FDA-0178 Source: U.S. Food and Drug Administration (FDA) Page 8

10 Fagron Sterile Services Issues Voluntary Nationwide Recall of Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL and Neostigmine Methylsulfate 1mg/mL, 3mg per 3mL, in a 5mL syringe Due to Mislabeling [Posted 06/29/2018] Fagron Sterile Services is voluntarily recalling two (2) lots of Neostigmine Methylsulfate 5mL syringes to the user/hospital/clinic level. The specified product lots are being recalled because of a confirmed customer complaint that some syringe units containing Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL are incorrectly labelled as Neostigmine Methylsulfate 1mg/mL, 3mg per 3mL. Secondary packages are properly labelled as Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL. Risk Statement: In the event that 5mL rather than the intended 3mL is administered to a patient, adverse events from Neostigmine Methylsulfate overdosage can range from nausea, vomiting, diarrhea, excessive salivation and sweating, increased bronchial secretions, miosis, bradycardia or tachycardia, cardiospasm, bronchospasm, incoordination, muscle cramps, fasciculation, paralysis, to Cholinergic Crisis resulting in death. To date, Fagron has not received any reports of adverse events or injuries related to this recall. Neostigmine Methylsulfate Injection, USP is a cholinesterase inhibitor indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery supplied by Fagron Sterile Services in a single-use syringe and is produced by Fagron Sterile Services into 5mL or 3mL fill presentation of 1 mg/ml of Neostigmine Methylsulfate. The impacted product Neostigmine Methylsulfate 1mg/mL can be identified by the following: Lot Number Item Description NDC # C C Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL (API) Neostigmine Methylsulfate 1mg/mL, 3mg per 3mL, 5mL syringe (API) Beyond-Use Date /21/ /20/2018 The impacted lots were distributed nationwide directly to hospitals and surgical clinics. Fagron Sterile Services has notified its direct customers by telephone and is arranging for return and replacement of all recalled products. Hospitals or surgical clinics that have received impacted product should immediately examine stock and discontinue dispensing. Promptly contact Stericycle to arrange product return at , from Monday to Friday, 8:00am to 5:00pm EDT for instructions on how to return impacted product. Healthcare professionals which have the Neostigmine Methylsulfate products which are being recalled should stop use and return to Fagron Sterile Services. Consumers with questions regarding this recall can contact Fagron Sterile Services by phone at M-F 8:00am 5:00pm CDT. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Page 9

11 Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Source: U.S. Food and Drug Administration (FDA) Fluoroquinolone Antibiotics: FDA Requires Labeling Changes Due to Low Blood Sugar Levels and Mental Health Side Effects [Posted 07/10/2018] ISSUE: FDA is strengthening the current warnings in the prescribing information that fluoroquinolone antibiotics may cause significant decreases in blood sugar and certain mental health side effects. BACKGROUND: Fluoroquinolone antibiotics are approved to treat certain serious bacterial infections, and have been used for more than 30 years. They work by killing or stopping the growth of bacteria that can cause illness. Without treatment, some infections can spread and lead to serious health problems. Most fluoroquinolone antibiotic drug labels include a warning that blood sugar disturbances, including high blood sugar and low blood sugar and depending on the fluoroquinolone antibiotic class, a range of mental health side effects are already described under Central Nervous System Effects in the Warnings and Precautions section of the drug label, which differed by individual drug. RECOMMENDATION: The new label changes will add that low blood sugar levels, also called hypoglycemia, can lead to coma and the new label will also make the mental health side effects more prominent and more consistent across the systemic fluoroquinolone drug class. The mental health side effects to be added to or updated across all the fluoroquinolones are: disturbances in attention disorientation, agitation, nervousness memory impairment serious disturbances in mental abilities called delirium. FDA continues to monitor and evaluate the safety and effectiveness of medicines after we approve them and they go on the market. In the case of fluoroquinolones, we reviewed reports of cases submitted to FDA and the published medical literature of apparently healthy patients who experienced serious changes in mood, behavior, and blood sugar levels while being treated with systemic fluoroquinolones. Patients should tell your health care professionals if you are taking a diabetes medicine when your health care professional is considering prescribing an antibiotic, and also if you have low blood sugar or symptoms of it while taking a fluoroquinolone. For patients with diabetes, your health care professional may ask you to check your blood sugar more often while taking a fluoroquinolone. Early signs and symptoms of low blood sugar include: confusion pounding heart or very fast pulse Page 10

12 dizziness pale skin feeling shaky sweating unusual hunger trembling headaches weakness irritability unusual anxiety Health care professionals should be aware of the potential risk of hypoglycemia sometimes resulting in coma, occurring more frequently in the elderly and those with diabetes taking an oral hypoglycemic medicine or insulin. Alert patients of the symptoms of hypoglycemia and carefully monitor blood glucose levels in these patients, and discuss with them how to treat themselves if they have symptoms of hypoglycemia. Inform patients about the risk of psychiatric adverse reactions that can occur after just one dose. Stop fluoroquinolone treatment immediately if a patient reports any central nervous system side effects, including psychiatric adverse reactions, or blood glucose disturbances and switch to a nonfluoroquinolone antibiotic if possible. Stop fluoroquinolone treatment immediately if a patient reports serious side effects involving the tendons, muscles, joints, or nerves, and switch to a non-fluoroquinolone antibiotic to complete the patient s treatment course. Health care professionals should not prescribe fluoroquinolones to patients who have other treatment options for acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, and uncomplicated urinary tract infections because the risks outweigh the benefits in these patients. Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online: Download form or call to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to FDA-0178 Source: U.S. Food and Drug Administration (FDA) Page 11

13 STUDIES AND RECENT TOPICS Ranibizumab Shows Improved Outcomes for Patients with Concurrent DME, Macular Nonperfusion June 19, 2018 According to the results of a recent post hoc analysis for the RIDE and RISE studies, participants who had diabetic macular edema (DME) and concurrent baseline macular nonperfusion (MNP) experienced improved outcomes when treated with ranibizumab. Source: mdmag.com New flu vaccine only a little better than traditional shot June 20, 2018 A newer kind of flu vaccine only worked a little bit better in seniors this past winter than traditional shots, the government reported Wednesday. Overall, flu vaccines barely worked at all in keeping people 65 and older out of the hospital, with roughly 24 percent effectiveness. Source: apnews.com FDA slaps new bladder cancer limits on Merck's Keytruda, Roche's Tecentriq June 22, 2018 Last month, the FDA warned that immuno-oncology stars from Merck and Roche might actually be hurting some previously untreated bladder cancer patients survival chances. And now, it s followed up by narrowing the drugs labels. The agency has restricted use of Merck s Keytruda and Roche s Tecentriq among patients with locally advanced or metastatic bladder cancer who aren t eligible for cisplatincontaining chemo. Specifically, within that population, Keytruda is now OK d only for patients whose tumors express levels of the biomarker PD-L1 that meet a combined positive score of 10 or higher. Tecentriq, meanwhile, can only be used for those whose PD-L1 immune cells cover 5% or more of their tumor area. Source: fiercepharma.com The Common Drug That May Make Opioid Overdose Five Times As Likely June 25, 2018 Opioid overdoses continue to increase, accounting for nearly two-thirds of all overdose deaths in the US, and a high percentage of those overdoses also include other drugs. A new study shows that the combination of opioids with one common class of drugs in particular is especially risky in the first 90 days of concurrent use. Those drugs are benzodiazepines (often called "benzos"), the class that includes Page 12

14 alprazolam (Xanax), diazepam (Valium), and clonazepam (Klonopin), meds frequently prescribed to alleviate anxiety. Source: forbes.com FDA Repays Industry by Rushing Risky to Market June 26, 2018 Nuplazid, a drug for hallucinations and delusions associated with Parkinson s disease, failed two clinical trials. In a third trial, under a revised standard for measuring its effect, it showed minimal benefit. Overall, more patients died or had serious side effects on Nuplazid than after receiving no treatment. Source: propublica.org Betamethasone prevents human rhinovirus- and cigarette smoke- induced loss of respiratory epithelial barrier function June 26, 2018 The respiratory epithelium represents a first line of protection against airborne particles, including pathogens and allergens, and plays an important role in the regulation of airway inflammation and host defense1. The nasal and the bronchial epithelium are naturally exposed to a variety of different potentially damaging factors, which may injure the integrity of the mucosa by different mechanisms. Infections with respiratory viruses, exposure to cigarette smoke and/or exhaust fume as well as to protease-containing bioparticles and endogenous inflammatory factors are among the commonly encountered factors offending the respiratory tract. Source: nature.com Brain-protein structure could point way to safer prescription drugs June 27, 2018 The musician Tom Petty last year joined a long line of high-profile stars to hit the headlines for dying from an accidental overdose of prescription painkillers and tranquillizers. The risks of opioid painkillers dominate the news. But the other half of the deadly mixture in such overdose cases deserves attention, too. It s typically a medicine from a class of drugs called benzodiazepines or more colloquially benzos. Source: nature.com US hospitals grapple with prolonged injected opioid shortage June 27, 2018 There is another opioid crisis happening in the U.S., and it has nothing to do with the overdose epidemic: Hospitals are frequently running out of widely used injected painkillers. Manufacturing shortages are forcing many doctors and pharmacists to sometimes ration injected opioids, reserving Page 13

15 them for the patients suffering most. Other patients get slower-acting or less effective pain pills, alternatives with more side effects or even sedation. Source: apnews.com Intravenous Eptinezumab Effectively Reduces Monthly Migraine Days June 28, 2018 A single intravenous 100 mg and 300 mg dose of eptinezumab is effective in reducing monthly migraine days (MMD) in patients with chronic migraine, according to a study presented by Paul Winner, DO, of the Palm Beach Headache Center/Premiere Research Institute at the 60th Annual Scientific Meeting of the American Headache Society, June 28-July 1, 2018 in San Francisco, California. Source neurologyadvisor.com Chronic pain patients, overlooked in opioid crisis, getting new attention from top at FDA July 2, 2018 Chronic pain patients and the groups that represent them say the escalating government response to opioid addiction ignores their need for the painkillers and doctors who will prescribe them, leaving some out of work, bedridden and even suicidal. Source: usatoday.com Fentanyl Is Causing Almost Half of All Overdose Deaths, Research Shows July 2, 2018 In a May 2018 research letter, the American Medical Association noted that of 2016 s more than 42,000 overdose deaths, nearly 46% involved fentanyl. Now, a study of a major metropolitan area is following suit, showing that national data of the opiate crisis is supported by smaller samples within a state. Source: fortune.com Metformin Could Accelerate Idiothatic Pulmonary Fibrosis Care July 5, 2018 New research has found that cell metabolism-targeting therapy metformin commonly prescribed to patients with diabetes can reverse the effects of lung fibrosis. At the conclusion of about 2 years of pre-clinical research, University of Alabama at Birmingham (UAB) Department of Medicine researchers Jaroslaw Zmijewski, PhD, and Victor Thannickal, MD have presented evidence from lung tissue-based analysis which showed the progressive disease can be resolved with acceleration by the non-insulin-dependent diabetes drug. Source: mdmag.com Page 14

16 Drugmakers try evasion, tougher negotiations to fight new U.S. insurer tactic July 5, 2018 In the escalating battle over U.S. prescription drug prices, major pharmaceutical companies are scrambling to limit the economic damage from a new U.S. insurer tactic that coaxes patients away from expensive drugs. Source: forbes.com FDA: New Warnings for Fluoroquinolones July 10, 2018 Manufacturers of fluoroquinolone antibiotics must update their labeling to warn about mental health issues and potential low blood sugar adverse reactions, the FDA said Tuesday. The labeling changes come after what the agency described as a "comprehensive review of the FDA's adverse event reports and case reports published in the medical literature," the agency said in a Drug Safety Communication. Source: medpagetoday.com Page 15

17 RECALLS Product Type Product Description Classificat ion Code Info Reason for Recall Recalling Firm Neostigmine Methylsulfate Injection Solution, 5 mg per 5 ml, 1 mg per ml, 5 ml prefilled syringe, 5 syringes per package, Rx only, Fagron Sterile Services, ICB Laboratories, 8710 E 34th St. N., Wichita, KS 67205, NDC Class I Lot #: C , BUD: 09/21/ 18. Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per ml, 5 mg per 5 ml may be incorrectly labeled as Neostigmine Methylsulfate 1 mg per ml, 3 mg per 3 ml. Fagron Compoun ding Services LLC dba Neostigmine Methylsulfate Injection Solution, 3 mg per 3 ml, 1 mg per ml, 3 ml prefilled syringe, 5 syringes per package, Rx only, Fagron Sterile Services, ICB Laboratories, 8710 E 34th St. N., Wichita, KS 67205, NDC Class I Lot #: C , BUD: 09/20/ 18 Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per ml, 5 mg per 5 ml may be incorrectly labeled as Neostigmine Methylsulfate 1 mg per ml, 3 mg per 3 ml. Fagron Compoun ding Services LLC dba Atorvastatin Calcium Tablets, 80 mg*, 90-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Lot #: T800064, Exp 12/2019 Presence of Foreign Substance: A product complaint was received for a defective tablet with an embedded foreign object observed in a bottle. Dr. Reddy's Laborator ies, Inc. Page 16

18 Product Type Product Description Srikakulam INDIA, NDC UPC Classificat ion Code Info Reason for Recall Recalling Firm 0.9% Sodium Chloride Injection, USP, 250 ml bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC % Sodium Chloride Injection, USP, 100 ml bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC Lot #: JT, JT, Exp. 01/01/2020 Lot #: JT, Exp 01/012020; JT, Exp 02/01/2020 Lack of assurance of sterility: Bags have potential to leak. Lack of assurance of sterility: Bags have potential to leak. ICU Medical Inc. ICU Medical Inc. 5% Dextrose Injection, USP, 250 ml bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC Lot #: JT, Exp 08 /01/2019 Lack of assurance of sterility: Bags have potential to leak. ICU Medical Inc. fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 ml, 10 mcg per ml prefilled syringe, Rx only, Advanced Pharma an FDA Regulated 503B Outsourcing Facility 9265 Kirby Dr., Houston, TX 77054, NDC Lot #: 6/12/ S, BU D 9/10/18 Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated on the label. Advanced Pharma Inc. Page 17

19 Product Type Product Description Classificat ion Code Info Reason for Recall Recalling Firm Irinotecan Hydrochloride Injection, USP, 100 mg/5 ml (20 mg/ml), 1 x 5 ml Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceuticals, LLC, Orlando, FL ; Manufactured by: Ingenius Pharmaceuticals, GmbH Ticino 6917, Switzerland, NDC Lot #: , , ; Ex p. 08/19 Superpotent Drug: High out of specification assay value results for potency. Ingenus Pharmac euticals Llc Irinotecan Hydrochloride Injection, USP, 40 mg/2 ml (20 mg/ml), 1 x 2 ml Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceuticals, LLC, Orlando, FL ; Manufactured by: Ingenius Pharmaceuticals, GmbH Ticino 6917, Switzerland, NDC Lot #: , , ; Ex p. 08/19 Superpotent Drug: High out of specification assay value results for potency. Ingenus Pharmac euticals Llc Page 18

20 Product Type Product Description Classificat ion Code Info Reason for Recall Recalling Firm Morphine Sulfate 1 mg/ml (preservative free; sulfite free) 2 ml fill 3 ml syringe, SCA Pharmaceuticals, LLC, Windsor, CT Lot # @44, Ex p 06/21/201 8 Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage. SCA Pharmac euticals, LLC Fentanyl (as citrate) 10 mcg/ml in 0.9% Sodium Chloride 250 ml bag, SCA Pharmaceuticals, LLC, Windsor, CT Lot # @19, @31, @49, @53, @9, @33, Exp 6/26/20 18 Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage. SCA Pharmac euticals, LLC Fentanyl (as citrate) 2 mcg/ml + Bupivacaine HCL % in 0.9% Sodium Chloride 250 ml bag, SCA Pharmaceuticals, LLC, Windsor, CT Lot # @27, @40, Exp 06/ 28/2018 Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage. SCA Pharmac euticals, LLC Diltiazem HCL 1 mg/ml in 125 ml 0.9% Sodium Chloride 100 ml bag (total volume 125 ml) (125 mg), SCA Pharmaceuticals, Lot # , , , , , , , Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage. SCA Pharmac euticals, LLC Page 19

21 Product Type Product Classificat Code Info Description ion LLC, Windsor, CT 84, , , , Exp 07/26/ /27/2018 Reason for Recall Recalling Firm Norepinephrine Bitartrate 4 mg (16 mcg/ml) in 0.9% Sodium Chloride 250 ml bag, SCA Pharmaceuticals, LLC, Windsor, CT Lot # , , , , , , Exp 06/19/ /03/ 2018 Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage. SCA Pharmac euticals, LLC Norepinephrine Bitartrate 8 mg (32 mcg/ml) in 0.9% Sodium Chloride 250 ml bag, SCA Pharmaceuticals, LLC, Windsor, CT Lot # , , , , , , , , , , Exp 0 6/18/ /11/2018 Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage. SCA Pharmac euticals, LLC Norepinephrine Bitartrate 16 mg (64 mcg/ml) in 0.9% Sodium Chloride 250 ml bag, SCA Pharmaceuticals, LLC, Windsor, CT Lot # , , , , , , , Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage. SCA Pharmac euticals, LLC Page 20

22 Product Type Product Description Classificat ion Code Info 78, , , , , , , , , Exp 06/19/ /03/ 2018 Reason for Recall Recalling Firm Phenylephrine HCL 10 mg in 0.9% Sodium Chloride 250 ml Bag (40 mcg/ml), SCA Pharmaceuticals, LLC, Windsor, CT Lot # @24, Ex p 06/21/201 8 Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage. SCA Pharmac euticals, LLC Phenylephrine HCL 40 mg in 0.9% Sodium Chloride 250 ml Bag (160 mcg/ml), SCA Pharmaceuticals, LLC, Windsor, CT Lot # @24 Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage. SCA Pharmac euticals, LLC Phenylephrine HCL 20 mg in 0.9% Sodium Chloride 250 ml Bag (160 mcg/ml), SCA Pharmaceuticals, LLC, Windsor, CT Lot # @29, Ex p 06/21/201 8 Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage. SCA Pharmac euticals, LLC Phenylephrine HCL 50 mg in 0.9% Sodium Chloride 250 ml Bag (200 Lot # @2, Exp 06/27/2018 Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential SCA Pharmac euticals, Page 21

23 Product Type Product Description mcg/ml), SCA Pharmaceuticals, LLC, Windsor, CT Classificat ion Code Info for leakage. Reason for Recall Recalling Firm LLC Phenylephrine HCL 80mg in 0.9% Sodium Chloride 250 ml Bag (320 mcg/ml), SCA Pharmaceuticals, LLC, Windsor, CT Lot # @25, Ex p 06/26/201 8 Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage. SCA Pharmac euticals, LLC eb5 Skincare that Works. Age Spot Treatment. Skin Lightening Cream with 2% Hydroquinone ml / 6 fl oz carton containing a tube. Manufactured For: EB5 Corporation Portland, OR Carton Bar Code: Batch B4276 A EXP 03/20 19 Failed Stability Specifications: Out-of-specification for viscosity, ph and specific gravity Eb5 Corporati on Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application vials and 12 applicators, 8 ml per box, Manufactured For: MedGyn Products, Inc., 100 W. Industrial Rd., Lot #s: all lot s within expi ry CGMP Deviations: The manufacturer of this product recalled because they were not manufactured under current good manufacturing practices. Medgyn Products, Inc. Page 22

24 Product Type Product Description Addison, IL USA; Manufactured By: BioDiagnostics Intl, 555 West Lambert Road Unit-C, Brea, CA 92821, NDC Classificat ion Code Info Reason for Recall Recalling Firm Acetylcysteine for Injection 6 g/30 ml (200 mg/ml). Rx Only. Manufactured by Akron Inc., Lake Forest, IL NDC Lots: A, Exp. 06/ 2018; A, Exp. 11/ 2018; A, Exp. 06/ 2019; A, Exp. 09/ 2019 CGMP Deviations Akorn, Inc. Nitrofurantoin Oral Suspension USP, 25mg/5mL, 230 ml Bottle, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, UPC , NDC Lot#: S , Exp. 02/ 2019; , Exp. 08/2 019 Subpotent Drug and Failed Content Uniformity. LUPIN SOMERSE T Page 23

25 Product Type Product Description Classificat ion Code Info Reason for Recall Recalling Firm Admelog Solostar (insulin lispro injection), 100 units/ ml (U-100) injection, packaged in 3mL prefilled pens, 1 pen per box, Rx only, Physician Sample - Not For Sale, Sanofi- Aventis U.S. LLC, Bridgewater, NJ 08807, NDC Lot #: 7F021 B, Exp 6/30/ 20 Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature. Sanofi- Aventis U.S. LLC Buffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic Use (Concentration=1 0 mg/ml) 0.25 ml Total Volume, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR Lot #: @21, Ex p 7/1/2018; @ 9, Exp 7/ 5/2018; @24, @ 31, @32, Exp 7 /12/2018; @2 1, Exp 7/25/ 2018; @11, Ex p 7/26/2018 Subpotent Drug: Stability data does not support the current expiration dating of 55 days after compounding. SCA Pharmac euticals Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 ml bottle, Rx Only, Manufactured by: Actavis Laboratories UT, Lot #s: , EXP 10/ 18; , , E XP 11/18; , EXP 07/19; , Failed Impurities and Degradation Specifications and Subpotent Drug: out-ofspecification (OOS) test results for below assay and above specification for degradants. Teva Pharmac euticals USA Page 24

26 Product Type Product Description Inc., Salt Lake City, UT USA; Distributed by: Actavis Pharmac, Inc., Parsippany, NJ USA, NDC Classificat ion Code Info 7, EXP 01/20 Reason for Recall Recalling Firm Potassium Chloride For Injection Concentrate syringe 40 meq/20 ml (2 meq/ml), Rx only, Medi- Fare Drug Pharmaceutical Compounding 300 West Pine St., Blacksburg, SC Lot: Exp.: 08/20/18 CGMP Deviations: Syringes were filled with 19mL of potassium chloride when the labels displayed a fill of 20mL. Medi- Fare Drug and Home Health Center Atorvastatin Calcium Tablets, 10 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam INDIA, NDC I Lot #: T600327, Exp 07/18; T700213, T700215, Exp 04/19 Failed Impurities/Degradation Specifications Dr. Reddy's Laborator ies, Inc. 0.2% ROPivacaine - OnQ Pump, (ROPivacaine HCL (USP) 1100mg, 0.9% Sodium Chloride (USP) QS 550 ml, single dose pump. For: Lot # 5/14/ , BUD 6/13/2018; 5/22/ , BUD 6/21/ Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Page 25

27 Product Type Product Description Vidant Medical Center, By: Avella of Houston, 9265 Kirby Dr., Houston, TX NDC: Classificat ion Code Info 2018 Reason for Recall Recalling Firm cefazolin 2 gm in NS 100mL. cefazolin Sodium (USP) 2gm, 0.9% Sodium Chloride (USP) 100mL. Volume 110 ml. Single dose bag. Avella of Houston 9265 Kirby Dr., Houston, TX NDC: Lot # 4/27/ P, 4/27/ P, BUD 6/26 /2018 Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. ephedrine 50mg, 50 mg/10 ml (5 mg per ml) (Ephedrine Sulfate, USP 50mg in 0.9% Sodium Chloride, USPQS 10mL. 10 ml- Sterile use dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX NDC Lot # 3/5/ S, 3/5/ S, 3/5/ S, 3/5 / S, 3/5/ S, BUD 7/3 /2018; 5/10 / S, 5/10/ S, BUD 9/ 7/2018; Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Page 26

28 Product Type Product Description Classificat ion Code Info Reason for Recall Recalling Firm EPINEPHrine (USP) 4 mg, 5% Dextrose For Inj. (USP) 250 ml Volume: 254 ml single dose bag. For: Peninsular Regional Medical Center. By: Advanced Pharma, 9265 Kirby Dr., Houston, TX NDC Lot # 5/4/ P, BUD 6/ 18/2018; 5/ 10/ P, 5/10/ P, BUD 6/24 /2018; 5/11 / P, B UD 6/25/20 18; 5/14/ P, BUD 6 /28/2018; 5 /17/ P, BUD 7/1/20 18; 5/24/ P, 5/24/ P, BU D 7/7/2018; 5/25/ P, BUD 7/9/ 2018; 5/30/ P, BU D 7/14/201 8; 5/31/ P, BUD 7/ 17/2018. Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. EPINEPHrine (USP) 4 mg, 0.9% Sodium Chloride (USP) 250 ml Volume: 254 ml Lot # 4/30/ P, BUD 6 /14/2018; 5 /22/ Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Page 27

29 Product Type Product Description single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX NDC Classificat ion Code Info 82325P, BU D 7/6/2018. Reason for Recall Recalling Firm fentanyl (10 mcg per ml) in 0.95 Sodium Chloride, USP QS 1mL. Volume 1mL. Single dose Syringe. For: Hunt Regional Medical Center, By: Advanced Pharma, 9265 Kirby Dr,., Houston, TX NDC Lot # 5/3/ S, BUD 8 /1/2018; 5/ 10/ S, BUD 8/8/20 18; 6/1/ S, BUD 8/ 30/2018; 6/ 4/ S, BUD 9/2/ Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. HEPARIN 25,000 Units in 5% Dextrose (Heparin Sodium, USP 25,000 Units, 5% Dextrose Inj., USP 250 ml) Volume: 255 ml. Single dose bag. Avella Specialty Pharmacy, N 19th Avenue, Phoenix AZ NDC Lot # @92, BUD 8/23/ 2018; @7 8, BUD 8/24 /2018 Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Page 28

30 Product Type Product Description Classificat ion Code Info Reason for Recall Recalling Firm Midazolam 1 mg/ml (Midazolam HCL (USP) 100 mg, Sodium Chloride, USP QS 100 ml) Volume: 100 ml. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston TX NDC Lot # 5/7/ P, BUD 9/4/ 2018; 5/22/ P, BUD 9/ 19/2018; 5/ 3/ P, BUD 8/31/2018. Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. HYDROmorphone 1 mg/ml (HYDROmorphone HCL (USP) 50 mg, 0.9% Sodium Chloride (USP) QS 50 ml) Volume: 50mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX. NDC Lot # 5/16/ S, BUD 8/1 4/2018. Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. MAGnesium 4gm in NS 100 ml (MAGnesium SULfate (USP) 4 gm, 0.9% Sodium Chloride (USP) 100 ml). Volume: 108 ml. Single dose bag. For: Gaston Memorial Hospital By: Avella of Houston, 9256 Kirby Dr., Houston, TX Lot # 5/1/ P, BUD 7 /30/2018. Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Page 29

31 Product Type Product Description NDC: Classificat ion Code Info Reason for Recall Recalling Firm Midazolam 1 mg/ml (Midazolam HCL (USP) 100 mg, Sodium Chloride, USP QS 100 ml) Volume: 100 ml. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston TX NDC Lot # 5/7/ P, BUD 9/4/ 2018; 5/22/ P, BUD 9/ 19/2018; 5/ 3/ P, BUD 8/31/2018. Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. MORphine 1 mg/ml (Morphine Sulfate, USP 100mg, 0.9% Sodium Chloride, USP QS 100 ml). Volume 100 ml. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX NDC Lot #: 5/15/ P, BUD; 9 /12/2018; 5 /16/ P, BU D 9/13/ Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. NORepiNEPHrine 8 mg (norepinephrine Bitartrate (USP) 8 mg added to 5% Dextrose Inj. (USP) 250 ml. (Concentration 32 mcg/ml) Volume: Lot #4/23/ P, 4/23/ P, BUD 6/22 /2018;4/30/ P, 4/30/ Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Page 30

32 Product Type Product Description 258 ml. Single dose bag. Avella of Houston, 9265 Kirby Dr. Houston, TX NDC Classificat ion Code Info 5P, BUD 6/2 9/2018; 5/1 / P, BUD 6 /30/2018; 5 /8/ P, BU D 7/7/2018. Reason for Recall Recalling Firm PHENYLephrine 40 mg (PHENYLephrine HCL (USP) 40 mg, 5%Dextrose Inj., USP 250 ml) Volume: 254 ml. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX NDC Lot # 5/23/ P, BUD 8/6 /2018. Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Vancomycin 1.25gm in D5W 250 ml. ( Vancomycin HCL (USP) 1.25 gm, 5% Dextrose Inj. (USP) 250 ml) Volume: 262 ml. Single dose bag. Avella Specialty Pharmacy, 24416N 19th Avenue, Phoenix, AZ NDC Lot # @92, @91, 13 BUD 7 /9/2018; 13 BUD 7 /13/2018; @61, BUD 7/15/2018 Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Page 31

33 Product Type Product Description Classificat ion Code Info Reason for Recall Recalling Firm 0.2% ROPivacaine, (Ropivacaine HCL PF, USP 500mg, 0.9% Sodium Chloride, USP QS 250 ml). Volume 250 ml. Single dose Cassette. For: Parkland Memorial Hospital. By: Advanced Pharma, 9225 Kirby Dr. Houston, TX Parkland Memorial Hospital NDC Lot 5/14/ Y EXP 06/ 28/2018 Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. ephedrine Sulfate, USP 50mg in 0.9% Sodium Chloride USP QS 10mL. 50 mg/10 ml (5 mg/ml). Volume: 10 ml. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX NDC Lot #: 05/10 / S, BUD 9 /7/2018 Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. fentanyl 3 mcg/ml, 0.1% Bupivacaine, Fentanyl Citrate, USP 750 mcg, Bupivacaine HCL PF, USP, 250 mg, Lot #: 5/14/ Y, BU D 6/28/ Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Page 32

34 Product Type Product Description 0.9% Sodium Chloride, USP QS 250 ml. Volume: 250mL. Single dose Cassette. For: Methodist St. John Hospital, By: Advanced Pharma, 9265 Kirby Dr., Houston, TX NDC Classificat ion Code Info Reason for Recall Recalling Firm fentanyl 5 mcg Citrate, USP 5 mcg in 0.9% Sodium Chloride, USP QS 0.5mL. (10 mcg per ml) 5 mcg in 0.5 ml. Volume: 0.5 ml. Single dose syringe. For Cook Children's Med Ctr. By: Advanced Pharma, 9265 Kirby Dr., Houston TX NDC Lot #: 5/24/ S, BU D 8/22/ Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. fentanyl 2 mcg/ml, 0.125% ROPivacaine, Fentanyl Citrate, USP 300 mcg, Ropivacaine HCL PF, USP mg, 0.9% Sodium Chloride, USP QS 150 ml. Volume: 150 ml. Single dose cassette For: Lot #: 5/14/ Y, BU D 6/28/ Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Page 33

35 Product Type Product Description Methodist Dallas Medical Center. By: Advanced Pharma, 9265 Kirby Dr., Houston, TX NDC Classificat ion Code Info Reason for Recall Recalling Firm HEPARIN 12,500 Units in 5% Dextrose. (Heparin Sodium, USP 12,500 Units, 5% Dextrose Inj., USP 250 ml) Volume: ml. Single dose bag. Avella Specialty Pharmacy, N 19th Avenue Phoenix, AZ NDC Lot #: @6 5, @64, 13 BUD 8 /19/2018. Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. HEPARIN 1,000 Units in NS 250mL. (Heparin Sodium, USP 1,000 Units, 0.9% Sodium Chloride, USP 250 ml) Volume: 251 ml. Single dose bag. For: Adventist Medical Center Hanford. By: Avella of Huston, 9265 Kirby Dr., Houston TX, NDC Lot #: 5/1/ P, BU D 7/30/ Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Page 34

36 Product Type Product Description Classificat ion Code Info Reason for Recall Recalling Firm HYDROmorphone 1 mg/ml (HYDROmorphone HCL (USP) 30 mg, 0.9% Sodium Chloride (USP) QS 30 ml) Volume: 30mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX. NDC Lot #: 3/15/ M, BUD 6 /13/2018. Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. HYDROmorphone 0.2mg/mL. (Hydromorphone HCL (USP) 20 mg, 0.9% Sodium Chloride (USP) QS 100 ml) Volume: 100mL. Single dose bag. Advanced Pharma, 9265 Kirby Dr., Houston, TX. NDC Lot #: 4/26/ P, BUD 8/ 9/2018; 5/1 4/ P, BUD 8/27/2018. Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. MAGnesium 1gm in NS 100 ml (MAGnesium SULfate (USP) 1 gm, 0.9% Sodium Chloride (USP) 100 ml). Volume: Lot #: 5/15/ P, BU D 8/13/ Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Page 35

37 Product Type Product Description 102 ml. Single dose bag. For: Salt Lake Regional Med Ctr By: Avella of Houston, 9256 Kirby Dr., Houston, TX NDC: Classificat ion Code Info Reason for Recall Recalling Firm MAGnesium 2gm in NS 100 ml (MAGnesium SULfate (USP) 2 gm, 0.9% Sodium Chloride (USP) 100 ml). Volume: 104 ml. Single dose bag. For: Desert Regional Med Ctr By: Avella of Houston, 9256 Kirby Dr., Houston, TX NDC: Lot #: 5/2/ P, BU D 7/31/201 8; 5/9/ P, BUD 8/7 /2018; 5/18 / P, B UD 8/16/ Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. MORphine 1 mg/ml (Morphine Sulfate, USP 250mg, 0.9% Sodium Chloride, USP 250 ml). Volume 255 ml. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX NDC Lot #:2/26/ P, BUD 6/2 6/2018. Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Page 36

38 Product Type Product Description Classificat ion Code Info Reason for Recall Recalling Firm MORphine 150 mg (Morphine Sulfate, USP 150mg in 0.9% Sodium Chloride, USP QS 30mL). Volume 30 ml. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX NDC Lot #:2/26/ M, BUD 6/ 26/2018. Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Midazolam 1 mg/ml (Midazolam HCL USP 30 mg, 0.9% Sodium Chloride, USP QS 30 ml) Volume: 30 ml. Single dose syringe. For: Methodist Willowbrook Hospital, By: Advanced Pharma, 9265 Kirby Dr., Houston TX NDC Lot #:5/11/ M, BU D 7/25/ Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Midazolam 0.5mg/mL (Midazolam HCL (USP) 50 mg, 0.9% Sodium Chloride, USP QS 100 ml) Volume: 100 ml. Single dose bag. For: Coral Gables Lot #:5/21/ P, BU D 8/4/2018; 5/22/ P, BUD 8/5/2 018; 5/25/ Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Page 37

39 Product Type Product Description Hospital, By: Advanced Pharma, 9265 Kirby Dr., Houston TX NDC Classificat ion Code Info 40810P, BU D 8/8/2018; 6/6/ P, BUD 8/20/ Reason for Recall Recalling Firm Midazolam 1 mg/ml (Midazolam HCL (USP) 55 mg, 0.9% Sodium Chloride, (USP) QS 55 ml) Volume: 55mL. Single dose syringe. Advanced Pharma, 9265 Kirby Dr., Houston TX NDC Lot #:5/14/ S, BUD 9/1 1/2018. Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. NORepiNEPHrine 16 (NORepiNEPHrine Bitartrate (USP) 16 mg, 5% Dextrose Inj. (USP) 250 ml. Volume: 266 ml. Single dose bag. Avella of Houston, 9265 Kirby Dr. Houston, TX NDC Lot #:4/26/ P, BUD 6/2 5/2018; 4/2 4/ P, BUD 6/23/2018. Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. NORepiNEPHrine Bitartrate, USP 160 mcg in 5% Dextrose, USP QS 10mL. Volume 10mL. Single dose syringe. Avella of Lot #: 5/7/ S, BUD 6 /21/2018; 5 /9/ S, B UD 6/23/20 Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Page 38