Enforcement Report - Week of May 2, 2018
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1 Enforcement Report - Week of May 2, 2018 Class I Event /15/ /24/2018 Press Release Bayer HealthCare Pharmaceuticals, Inc. 100 Bayer Blvd Whippany NJ United States Nationwide in the USA All Alka-Seltzer Plus packages with a full front panel instant Redeemable Coupon (IRC) affixed to the individual carton. The recalled products can be identified by checking the Bayer logo located on the lower left corner of the front of the carton. If the logo has an orange or green background, the product is included in the recall. 188,631 units Labeling: Label Mix-Up: Bayer is recalling all Alka-Seltzer Plus packages, with a green or orange Bayer logo located on the lower left corner of the front of the carton, because the ingredients on the front sticker may not match the actual product in the carton. D The recalled products can be identified by checking the Bayer logo located on the lower left corner of the front of the carton. If the logo has an orang e or green background, the product is included in the recall Class II Event /11/ /22/2018 Letter Time-Cap Laboratories, Inc. 7 Michael Ave Farmingdale NY United States Nationwide. 1/7
2 Ibuprofen Tablets, USP, 200 mg, a) 50 tablets (NDC ), b) 100 tablets (NDC ), c) 500 tablets (NDC ), d) 1000 tablets (NDC ), e) Bulk ( ) bottles, Brown, Manufactured for: Time Cap Labs, Inc., Farmingdale, NY 11735, Manufactured by: Marksans Pharma, Ltd., Verna, Goa , India D a) D167C, exp 2/18; b) D172C, exp 2/18, H057C, exp 6/18; c) D164C, exp 2/18, E135C, exp 3/18; d) D172C, exp 2/18, E135C, exp 3/18, F004C, ex p 5/18; e) D175C, D176C, D177C, D178C, D179C, D180C, D162C, D163C, D164C, D165C, D166C, D168C, D169C, D170C, D171C, D173C, E104 C, E105C, D191C, D192C, D193C, D194C, D195C, D196C, D197C, D198C, D199C, D200C, D201C, E106C, exp 2/18; L111C, F005C, F006C, F00 7C, F008C, H053C, H054C, H055C, H056C, exp 5/18; L112C, L113C, L114C, L115C, L116C, L117C, L118C, L119C, J008C, J009C, H057C, H058 C, exp 6/18; L120C, L121C, L122C, L123C, L124C, exp 8/18 Ibuprofen Tablets, USP, 200 mg, a) 50 tablet (NDC ), b) 100 tablet (NDC ), c) 500 tablet (NDC ), Brown, Distributed by Drug Mart, Food Fair, Medina, Ohio D a) D167C, exp 2/18, E135C, exp 3/18; b) D172C, exp 2/18; c) D167C, exp 2/18, E135C, exp 3/18 Ibuprofen Tablets USP 400 mg, a) 100 tablet (NDC ) and b) 500 tablet (NDC ) bottles, Rx, Manufactured for: Time Cap labs, Inc., Farmingdale, NY 11735, USA, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate Verna, Goa , India D a) M104C, exp 9/18, L016C, H092C, and H093C, exp 9/18 b) C128C, C129C, C130C, C132C, exp 3/18, HK6011, exp 7/18, L016C and H092C, exp 9/18, Ibuprofen Tablets USP 400 mg, 500 tablet bottles (NDC ), Rx, Distributed by Bi-Coastal Pharma International, Shrewsbury, NJ, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate Verna, Goa , India D C128C, C129C, exp 3/18 Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC ) and b) 500 tablet bottles (NDC ), Rx, Manufactured for: Time Caps Labs, Farmingdale, NY, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate Verna, Goa , India 2/7
3 D a) C135C, D044C, D045C, D038C, exp 3/18, F069C, exp 4/18, H095C, exp 9/18 b) C134C, C136C, D039C, D040C, D041C, D042C, D043C, exp 3/ 18, F043C F067C, F068C, D046C, D047C, exp 4/18, H094C, exp 7/18 H096C, L026C, and H095C, exp 9/18 Ibuprofen Tablets USP 600 mg, a) 100 tablets (NDC ) and b) 500 tablet bottles (NDC ), Rx, Distributed by: Bi-Coastal Pharma International, Shrewsbury, NJ, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate Verna, Goa , India D a) D044C, D038C, D043C, exp 3/18, b) C136C, exp 3/18, D039C, D040C, D041C, D042C, 3/18 Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC ), b) 500 tablet bottles (NDC ), Rx, Distributed by Drug Mart, Food Fair, Medina, Ohio D a) C135C, exp 3/18 b) C134C, exp 3/18 Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC ) and b) 500 tablet (NDC ) bottles, Rx, Manufactured for: Time Cap labs, Inc., Farmingdale, NY 11735, USA, Manufactured by: Marksans Pharma, Ltd., Verna, Goa , India D a) C139C, C140C, exp 2/18, F044C, exp 8/18; b) D048C, D049C, D050C, D051C, C142C, C137C, C138C, C139C, C141C, exp 2/18; D052C, K207 C, K208C, K209C, K210C, K211C, K212C, HM6122, HM6123, HM6124, HM6125, HM6126, K109C, K110C, K111C, HM6113, HM6114, HM6115, H M6116, HM6117, HM6118, F044C, H097C, H098C, H099C, H100C, H101C, K096C, K097C, K098C, K099C, K100C, K101C, K102C, exp 8/18; M1 05C, L017C, L018C, L019C, L020C, L021C, L022C, exp 9/18 Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC ) and b) 500 tablet (NDC ) bottles, Rx, Distributed by; Bi-Coastal Pharma International, Shrewsbury, NJ, Manufactured by: Marksans Pharma, Ltd., Verna, Goa , India D /7
4 a) C140C, exp 2/18; b) D049C, D050C, D051C, C142C, C137C, C138C, C141C, exp 2/18; D073C, D074C, exp 3/18 Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC ), b) 100 caplets (NDC ), c) 500 caplets (NDC ), and d) BULK (NDC ) bottles, Rx, Manufactured for: Time Cap labs, Inc., Farmingdale, NY 11735, Manufactured by: Marksans Pharma, Ltd., Verna, Goa , India D a) F066C b) F066C c) F066C Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC ), b) 100 caplets (NDC ), and c) 500 caplets (NDC ) bottles, Distributed by Drug Mart, Food Fair, Medina, Ohio 44256, Manufactured by: Marksans Pharma, Ltd., Verna, Goa , India D a) F066C b) F066C c) F066C Class II Event /11/ /26/2018 Press Release Premier Pharmacy Labs Inc 8265 Commercial Way Weeki Wachee FL United States Nationwide in the USA Morphine Sulfate 2 mg/ml PF Injection. 1 ml in a 3ml Sterile Single-Dose Syringe Commerical Way Weeki Wachee, FL NDC syringes 4/7
5 D Lots: MOR030518IJDSA, MOR030518IJDSB, MOR030518IJDSC, MOR030518IJDSD, MOR030518IJDSE BUD: 06/03/2018; Morphine Sulfate 4 mg/ml PF Injection. 1 ml in a 3ml Sterile Single-Dose Syringe Commerical Way Weeki Wachee, FL NDC syringes D Lots: MOR022318NWDSA, MOR022318NWDSB, MOR022318NWDSC, MOR022318NWDSD, MOR022318NWDSE BUD: 05/24/2018 Hydromorphone HCl 1 mg/ml PF INJ. 1mL in a 3mL Sterile Single-Dose Syringe Commercial Way Weeki Wachee, FL NDC syringes D Lots: HYD030118IJDSA, HYD030118IJDSB, HYD030118IJDSD, HYD030118IJDSE BUD: 05/30/2018 NEOstigmine Methylsulfate (1 mg/ml) 3mg per 3mL. 3mL Single Dose Syringe. Premier Pharmacy Labs Commercial Way Weeki Wachee, FL NDC syringes D Lot: NEO022218SVDS BUD: 8/21/2018 Not Yet Classified Event /13/ /7
6 Letter Lyne Laboratories, Inc. 10 Burke Dr Brockton MA United States to be entered Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) ml (4 fl. oz.) Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401, NDC , UPC units Subpotent Drug Lot #: FR1603, FR1604A, Exp. 05/2018 Fluocinolone Acetonide Topical Oil, 0.01% (Ear Drops) 20 ml, Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401, NDC , UPC units Subpotent Drug Lot#: FR1604B, FR1604C, FR 1604D, Exp. 06/2018 Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) ml (4 fl.oz.) Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401, NDC , UPC units Subpotent Drug Lot #: FR1601, FR1602, Exp. 05/2018 Not Yet Classified Event /23/2018 Letter 6/7
7 Mckesson Packaging Services 7101 Weddington Rd Nw Concord NC United States Nationwide with the US Diltiazem HCl Extended-Release Capsules, USP 120 mg, 100-count bottles, Rx only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY NDC: cartons Failed Dissolution Specifications. High dissolution results were obtained during stability testing. Lot #: , Exp. 12/2018 Diltiazem CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) 180 mg, 100-count bottles, Rx Only Mfg. By: Actavis 60 Columbia Rd., Bldg. B Morristown, NJ NDC cartons Failed Dissolution Specifications. High dissolution results were obtained during stability testing. Lot #: , Exp. 09/2018 Diltiazem HCl Extended-Release Capsules, USP 240 mg, 100-count bottles, Rx Only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY NDC: cartons Failed Dissolution Specifications. High dissolution results were obtained during stability testing. Lot #: , Exp. 12/ /7
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