Annexure. Reason for failure with Report No. (in Form-13)& Date Misbranded Report No / Dated
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1 Annexure List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/, For the Month of September, 2014 Sl. No. Name of Drugs/medica l device/cosmet ics 1 Paracetamol 2 Paracetamol 3 Paracetamol 4 Paracetamol 5 Paracetamol 6 Paracetamol 7 Paracetamol Batch No./Date of Manufacture/Date of Expiry/Manufactured By B. No. 448, B. No. 454, B. No. 446, B. No. 444, B. No. 455, B. No. 461, B. No. 442, Reason for failure with (in Form-13)& Date 09616/ / / / / / /20 Drawn By From
2 8 Paracetamol 9 Paracetamol 10 Paracetamol 11 Paracetamol 12 Paracetamol 13 Rabcam Paracetamol 15 Paracetamol B. No. 445, B. No. 449, B. No. 456, B. No. 447, B. No. 450, D/Mfg. May, 2014, B. No. RAB-078, D/Mfg. Nov, 2013, D/Exp. Oct, 2015, Peerpura Road, Roorkee, Uttarakhand. B. No. 458, B. No. 453, 09624/ / / / / / / /20
3 16 PD-MET-F Suspension 17 RAYZOLE TABLETS 18 NET-N-Clean Bleaching Powder 19 Handloom Cotton Rolled Bandage (Non-Sterile) B. No. PMF-09, D/Mfg. May, 2014, M/s Pharm Asia Drugs, Panchal Compound, Survey No. 78/1, PatwariHalke No. 17, New 45, Indore. B. No. BNT D/Mfg. Mar, 2014, D/Exp. Aug, 2015, M/s BROSE ENTERPRISE, 160, Nalhera, Anantpur, Iqbalpur Road, Roorkee, Uttarakhand B. No. (K) 383, D/Mfg. May, 2014, D/Exp. Oct, 2016, M/s Repacked By-Bajrang Chemicals, Barasat, Kolkata, West Bengal. B. No. 033, D/Mfg. Dec, 2013, D/Exp. NIL, NIL / / /20 /09/ Bleaching Powder 21 ROXYRAB SUSPENSIO N 22 Calcijoint 23 Rey Flam B. No. 593, D/Exp. NIL, M/s National Chemical & Perfumery Works, Fatasil, B. No. RAB-132 Peer Pura Road, Roorkee, Uttarakhand B. No. 13A-049, D/Mfg. Jan, 2013, D/Exp. Dec, 2014, M/s Unix Biotech, Jharmajri, Baddi, Dist. Solan , Himachal Pradesh. B. No. RAB-105, 86-87, Vill. MAkhiyaliDundi, Peerpura Road, Roorkee, /08/ / Disintegration 09606/ Disintegration, 09607/
4 Uttarakhand, Oflowin-OZ 25 Norfloxacin 26 Metronidazole Benzoate Oral Suspensions B. No. ABG4003BT, D/Mfg. Feb, 2014, D/Exp. Jan, 2016, M/s BHC Lab (P) Ltd., 91/2, DIC Baddi, Dist. Solan, , Himachal Pradesh. B. No , M/s Veejay Laboratories, EPIP, Amingaon, , B. No. MS/1405, D/Mfg. Jun, 2014, M/s Viva Pharma Pvt. Ltd., Jorhat, Disintegration 09642/ Dissolution 09639/ /20 27 Paracetamol 28 Ofloxacin&Or nidazole Suspensions 29 R-Panta AMPIRAB-C CAPSULES B. No. PKT-3027SB, D/Mfg. Sep, 2013, D/Exp. Aug, 2016, M/s Shiva Biogenetic Pharmaceuticals Pvt. Ltd., Vill. Manpura, Baddi, Dist. Solan, , Himachal Pradesh. B. No. DOSL-006, D/Mfg. Aug, 2013, D/Exp. Jul, 2015, M/s Laborate Pharmaceuticals India Ltd., Rajban Road, Nariwala, Paonta Sahib, Himachal Pradesh. B. No. RAB-0123 D/Mfg. Nov, 2013, D/Exp. Oct, 2015, Peer Pura Road, Roorkee, Uttarakhand B. No. RAB-117 Peer Pura Road, Roorkee, Uttarakhand Dissolution, 09666/ / Dissolution 09714/ /
5 31 Hemsyl Injection (Etamsylate Injection), B. No.: HAA1J32, Mfgdt: 10/2013, Expdt: 09/2016 Mfd by: M/s. Indoco Remedies Ltd., L-32, Verna Industrial Area, Verna, Goa Description & Particulate Matter32-8/2014- SS/DCA(E)- 217/1466Dt Polytaz Injection (Ceftriaxone &Tazobactum for Injection), B. No.: P Mfgdt: 11/2012 Expdt: 10/2014 Mfd by: M/s. Brooks Laboratories Ltd., Village: Kashipura, Nalagarh Road, Baddi , HP Constituted Solution & Particulate Matter 32-1/2014-SS/ DCA(N)-70/1449 Dt North, Ghaziabad, UP 33 C- Plus 1.5 gm (Ceftriaxone &Sulbactum for Injection), B. No.: PCZ Mfgdt: 01/2014, Expdt: 12/2015 Mfd by: M/s. Marc Laboratories Ltd. (U-III), Plot No. 112, HPSIDC, Baddi, Solan (HP). Clarity of Solution & Particulate Matter 32-18/2014-SS/ DCA(C)-47/1448 Dt Sub 34 Bupivacaine Heavy (Bupivacaine Hydrochloride & Dextrose Injection USP) B.No: I-3864, Mfgdt: 05/2013 Expdt: 04/2015 Mfd by: M/s. Jackson Laboratories Pvt. Ltd., Bye Pass, Majitha Road, Amritsar Description, Particulate Matter, of Bupivacaine, of Dextrose 32-18/2014-SS/ DCA(C)-04/1406 Dt Sub 35 Meparin 5 (Heparin Sodium) 1000 IU/ml Solution for Injection 5 ml, B.No: N-3176 Mfgdt: 07/2013 Expdt: 07/2016 Mfd by: M/s. Medchem International Ltd., A6, Banjara Garden, Road No. 12, Banjara Hills, Hyderabad , India Description & Particulate Matter 32-18/2014-SS/ DCA(C)-18/1266 Dt Sub
6 36 Lozep 0.5 (Clonazepam tabs IP 0.5mg) B.No: AA-1456 Mfgdt: 01/2013 Expdt: 12/2015 Mfd by: M/s. Psychotropics India Ltd., Plot No. 46 & 49, Sector 6A, IIE, SIDCUL Industrial Area, Ranipur, Haridwar Related Substances 32-13/2014-SS/ DCA(B)-98/1431 Dt Sub Bangalore 37 Amoxicillin Dispersible 250 mg B. No.: Mfgdt: Not Stated Expdt: 01/2016 Mfd by: M/s. Not Stated Uniformity of Dispersion 32-13/2014-SS/ DCA(B)-52/1297 Dt Sub Bangalore 38 Carbamine (Diethylcarba mazine Citrate IP 100mg), B. No.: FO12016 Mfgdt: 10/2012, Expdt: 09/2014 Mfd by: M/s. Ortin Laboratories Ltd., 275 & 278 (Part), IDA, Pashamilaram , Medak, AP Description 32-12/2014-SS/ DCA(H)- 126/1347 Dt Zonal Office Hyderabad 39 Ezelax (Bisacodyl Tablet I.P.) B. No.: ZT-8663 Mfgdt: 02/2013, Expdt: 01/2015 Does not conform to IP standard with respect to the test for Disintegration West CDTL, Mumbai Mfd by: M/s. Zee Laboratories, 47 Industrial Area, Paonta Sahib Pafenil 150 (Paracetamol Injection 2ml) B. No.: 13AD82 Mfgdt: 04/2013, Expdt: 03/2015 Does not conform to specification with respect to the test for PH West CDTL, Mumbai Mfd by: M/s. Pharmafabrikon, Unit-II, 91-1 SivagangaiRaod, Vilathur, Madurai Ibuprofen IP 400 mg B.No: BG137 Regn.No:CDTL/Form- 18/D/0394/ Mfd. Dt: Feb Exp. Dt: Jan Does not conform with respect to Test For Dissolution Zonal Office, Hyderabad CDTL, Chennai
7 MfdBy: Biogenetic Drugs Pvt.Ltd, Jharmazri Baddi , Dist-Solan HP 42 Dispersible Amoxycillin I.P (ANTEMOX- 250 DT) Batch No.-T5266 D/Mfg.- Dec D/Exp.-Nov Mfd. By M/s Jackson Laboratories Pvt. Ltd., Amritsar Majitha Road, Bye Pass, Amritsar Uniformity of Dispersion, Report No. LSD//0120/, 43 Ciprofloxacin e Hydrochloride I.P (CIPMARX- 500) Batch No. - CPT-4514, D/Mfg.-Jun. 2013, D/Exp.- May Mfd. By M/s A.K. Biotech Pvt. Ltd., Export Promotional Industrial Park, Kartholi Jammu Dissolution & LSD//0211/, 44 Ofloxacin&Or nidazole (Floxavin-OZ) Batch No. - FZ-28, D/Mfg.- Apr D/Exp.-Sep Mfd. By M/s Therawin Formulation 69-71, Jasmeet Nagar, Ambala City Disintegration Test LSD//0263/, 45 Paracetamol, Diclofenac sodium &Serratiopepti dase (Lyser DP ) Batch No.-B142008, D/Mfg.- May. 2014, D/Exp.-Apr. 2016, Mfd. By M/s Comed Chemicals Limited., Village Dassomajra, P.O. Bhud. Baddi, Tehsil Nalagarh, Solan (H.P) of Serratiopeptidase LSD//0213/,
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