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Date: 2014-04-09 Category: Not Applicable State: Union Government Country: India

Drugs Alert for the month of March 2014

Issued by Ministry of Health and Family Welfare · Central Drugs Standard Control Organization

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Executive Summary & Key Takeaways

What it means

  • This gazette notification is a drug alert for March 2014, issued by various Drugs Control Departments and CDSCO zones in India.
  • It lists drugs, medical devices, and cosmetics that failed quality tests, along with the batch number, manufacturing and expiry dates, manufacturer details, reason for failure, and the testing laboratory.

Key Changes

  • A total of 34 drugs/medical products are listed as failing quality tests.
  • Reasons for failure include: Dissolution issues, Assay discrepancies, Disintegration problems, pH and particulate matter issues, Sterility concerns, and Uniformity of Weight issues.
  • Testing was conducted by various Drugs Control Departments RDTLs (Regional Drugs Testing Laboratories) located in Guwahati, Chandigarh, Chennai and CDSCO (Central Drugs Standard Control Organization) testing zones located in Kolkata, Mumbai, Ghaziabad and Chennai.
  • Manufacturers listed are located across India, including Himachal Pradesh, Assam, Uttarakhand, Maharashtra, Delhi, Punjab, Tamil Nadu and West Bengal.
  • Some of the listed drugs include: Levocetirizine Dihydrochloride Tablets, Megarab-20 Tablets, Ranitidine Hydrochloride Tablets, Metronidazole Benzoate Oral Suspensions, Ofloxacine suspensions, Zencal Tablets, RINOSTAT + Tablets, MEBENDAZOLE Tablets, RAB-GENTA INJECTIONS, GEENOR – 400 Tablets, MATIPHYLLINE Tablets, ERYTHROMYCIN ESTOLATE TABLETS, OMEPRAZOLE CAPSULES, RIDNOR-400 TABLETS, Diclofenac Sodium & Nimesulide Capsules, Serratiopeptidase & Diclofenac Potassium Tablets, Nicardia Retard 20 Tablets, Sterodin Injection, Eprin 150 Tablets, Glimepiride Tablets IP 1mg, Donica-SR Capsules, Multiple Electrolytes & Dextrose Injection IP Type I, 500 ml, Orapaste Oral Paste and DICLOFENAC SODIUM TABLETS IP 50 mg.

Impact Analysis

Manufacturers

  • Action Item: Conduct thorough internal investigations, implement CAPA plans, and engage with regulatory authorities to address the deficiencies.

Distributors/Retailers

  • Action Item: Verify inventory, quarantine affected batches, and coordinate with manufacturers for returns and refunds.

Consumers/Patients

  • Action Item: Healthcare providers should be notified to monitor patients who may have received the affected drugs. Issue public advisory to inform consumers about the drug alert and advise them to consult healthcare professionals if they experience any adverse effects.

Regulatory Agencies

  • Action Item: Monitor manufacturer compliance, conduct follow-up inspections, and enforce penalties for non-compliance.

Our Company

  • Action Item: Contact suppliers to confirm the quality of materials and products, and implement additional quality control measures if necessary.

Key Entities Referenced

Drugs Control Department: Government agency responsible for regulating the manufacture, distribution, and sale of drugs and cosmetics. RDTL (Regional Drugs Testing Laboratory): Laboratory responsible for testing drugs and medical products to ensure they meet quality standards. CDSCO (Central Drugs Standard Control Organization): National regulatory body for pharmaceuticals and medical devices in India. Galpha Laboratories Ltd.: Manufacturer of LEVOCETIRIZINE DIHYDROCHLORIDE TABLETS, located in Baddi, Himachal Pradesh. Scott-Edil Pharmacia Ltd.: Manufacturer of MEGARAB-20 TABLETS and OFRIVID-OR SUSPENSIONS, located in Jharmajri, Himachal Pradesh. Concept Pharmaceuticals Ltd.: Manufacturer of RANITIDINE HYDROCHLORIDE TABLETS, located in Aurangabad, Maharashtra. Laborate Pharmaceuticals India Ltd.: Manufacturer of RANITIDINE TABLETS and OFLOXACIN & ORNIDAZOLE SUSPENSIONS, located in Paonta Sahib, Himachal Pradesh. Lolyds Pharmaceuticals: Manufacturer of METRONIDAZOLE BENZOATE ORAL SUSPENSIONS, located in Guwahati, Assam. Apple Formulations Pvt. Ltd.: Manufacturer of OFOXO – OZ SUSPENSIONS, located in Roorkee, Uttarakhand. Creative Healthcare Pvt. Ltd.: Manufacturer of ZENCAL TABLETS, located in Kashipur, Uttarakhand. CB Healthcare: Manufacturer of OFOXO SUSPENSIONS, located in Nalagarh, Himachal Pradesh. GS Pharmaceuticals Pvt. Ltd.: Manufacturer of CC-GO NF TABLETS, located in Roorkee, Uttarakhand. Innova Cap Tab: Manufacturer of RINOSTAT + TABLETS, located in Baddi, Himachal Pradesh. Danish Laboratories: Manufacturer of MEBENDAZOLE TABLETS, located in Ujjain, Madhya Pradesh. Argon Remedies Pvt. Ltd.: Manufacturer of RAB-GENTA INJECTIONS, located in Kashipur, Uttarakhand. Ghanshyam Pharmaceuticals: Manufacturer of GEENOR – 400 TABLETS, located in Kamrup, Assam. Unicure(India) Pvt. Ltd.: Manufacturer of MATIPHYLLINE TABLETS and OMEPRAZOLE CAPSULES, located in Noida, Uttar Pradesh. Hecatomb Laboratory Pvt. Ltd.: Manufacturer of ERYTHROMYCIN ESTOLATE TABLETS, located in Guwahati, Assam. Ridley Life Sciences Pvt. Ltd.: Manufacturer of RIDNOR-400 TABLETS, located in Delhi. TORQUE PHARMACEUTICALS PVT.LTD.: Manufacturer of Diclofenac Sodium & Nimesulide Capsules, located in Jharmajri, Himachal Pradesh. Proceed Formulations: Manufacturer of Serratiopeptidase & Diclofenac Potassium Tablets, located in Derabassi, Punjab. J.B. Chemicals & Pharmaceuticals Ltd.: Manufacturer of Nicardia Retard 20 Tablets, located in Ankleshwar, Gujarat. Union Drug Company Ltd.: Manufacturer of Sterodin Injection, located in Kolkata, West Bengal. Elder Pharmaceuticals Ltd.: Manufacturer of Eprin 150 Tablets, located in Navi Mumbai, Maharashtra. LA-Chemico Pvt. Ltd.: Manufacturer of Glimepiride Tablets IP 1mg, located in Barasat, West Bengal. BDH Industries Ltd.: Manufacturer of Donica-SR Capsules, located in Mumbai, Maharashtra. PDPL Parenteral Drugs (India) Ltd.: Manufacturer of Multiple Electrolytes & Dextrose Injection IP Type I, 500 ml, located in Indore, Madhya Pradesh. Palsons Drugs Pvt. Ltd.: Manufacturer of Orapaste Oral Paste, located in Kolkata, West Bengal. Cassel Research Laboratories Pvt Ltd.: Manufacturer of DICLOFENAC SODIUM TABLETS IP 50 mg, located in Chennai, Tamil Nadu.
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Drug Alert For the Month of March, 2014 Sl. Name of Batch No./Date of Reason for Drawn By From No. Drugs/medical Manufacture/Date of failure device/cosmetics Expiry/Manufactured By 1 LEVOCETIRIZI B. No. LVT-2001B, Dissolution Drugs Control RDTL, NE D/Mfg. Apr, 2012, Report No. Department, Guwahati DIHYDROCHLO D/Exp. Sep, 2014, 08748/2013- Assam RIDE TABLETS Mfg. By. 14 M/s Galpha Laboratories Ltd., Dated Thane, Baddi-173205, 05-03-2014 Himachal Pradesh 2 MEGARAB-20 B. No. S753777, Dissolution, Drugs Control RDTL, TABLETS D/Mfg. Jun, 2013, Assay Department, Guwahati D/Exp. May, 2015, Report No. Assam Mfg. By. 08762/2013- M/s Scott-Edil Pharmacia Ltd. 14 , Dated 56, EPIP, Phase I, Jharmajri- 07-03-2014 173205 3 MEGARAB-20 B. No. S752886, Dissolution, Drugs Control RDTL, TABLETS D/Mfg. Jul , 2012 , Assay Department, Guwahati D/Exp. Jun, 2014, Report No. Assam Mfg. By. 08763/2013- M/s Scott-Edil Pharmacia Ltd. 14 , Dated 56, EPIP, Phase I, Jharmajri- 07-03-2014 173205 4 RANITIDINE B. No. C3016, Assay Drugs Control RDTL, HYDROCHLORI D/Mfg. Aug , 2013, Report No. Department, Guwahati DE TABLETS D/Exp. July, 2016, 08846/2013- Assam Mfg. By. 14 M/s Concept Pharmaceuticals Dated Ltd. 14-03-2014 A-28/3, M.I.D.C, Chikalthana, Aurangabad - 431006 5 RANITIDINE B. No. RNIT-002, Assay Drugs Control RDTL, TABLETS D/Mfg. Jul, 2013, Report No. Department, Guwahati D/Exp. Jun, 2015, 08847/2013- Assam Mfg. By. 14 M/s Laborate Pharmaceuticals Dated India Ltd., Rajban Road, 14-03-2014 Nariwala, Paonta Sahib, Himachal Pradesh 6 METRONIDAZO B. No. MB143, Assay Drugs Control RDTL, LE BENZOATE D/Mfg. Jun,2013, Report No. Department, Guwahati ORAL D/Exp. May, 2015, 08848/2013- Assam SUSPENSIONS Mfg. By. 14 M/s Lolyds Pharmaceuticals, Dated Kalapahar Industrial Area, 14-03-2014 Guwahati-781016, Assam 7 OFOXO – OZ B. No. OXZ-1202, Assay Drugs Control RDTL, SUSPENSIONS D/Mfg. May,2012, Report No. Department, Guwahati D/Exp. Apr, 2014, 08871/2013- Nagaland Mfg. By. 14 M/s Apple Formulations Pvt. Dated Ltd., 19-03-2014Plot 208, Kishanpur, Roorkee, Uttarakhand-247667 8 ZENCAL B. No. BZT2001, Disintegration Drugs Control RDTL, TABLETS D/Mfg. Oct,2012, Report No. Department, Guwahati D/Exp. Sep, 2014, 08872/2013- Nagaland Mfg. By. 14 M/s Creative Healthcare Pvt. Dated Ltd., 19-03-2014 Plot 25, Kundeshwari, Kashipur, US Nagar, Uttarakhand. 9 OFOXO B. No. CBL-0892, Assay Drugs Control RDTL, SUSPENSIONS D/Mfg. Sep,2012, Report No. Department, Guwahati D/Exp. Aug, 2014, 08874/2013- Arunachal Mfg. By. 14 Pradesh M/s CB Healthcare, Dated Vill. Messa Tibba, Nalagarh, 19-03-2014 Solan, Himachal Pradesh 10 OFLOXACIN & B. No. DOSL-010, Assay Drugs Control RDTL, ORNIDAZOLE D/Mfg. Aug,2013, Report No. Department, Guwahati SUSPENSIONS D/Exp. Jul, 2015, 08875/2013- Assam Mfg. By. 14 M/s Laborate Pharmaceuticals Dated India Ltd., Rajban Road, 19-03-2014 Nariwala, Paonta Sahib, Himachal Pradesh 11 OFRIVID-OR B. No. S752527, Assay Drugs Control RDTL, SUSPENSIONS D/Mfg. May, 2012, Report No. Department, Guwahati D/Exp. Apr, 2014, 08873/2013- Assam Mfg. By. 14 M/s Scott-Edil Pharmacia Ltd. Dated , 19-03-2014 56, EPIP, Phase I, Jharmajri- 173205 12 CC-GO NF B. No. T 1209029, Disintegration Drugs Control RDTL, TABLETS D/Mfg. Sep, 2012, Report No. Department, Guwahati D/Exp. Aug, 2014, 08915/2013- Nagaland Mfg. By. 14 M/s GS Pharmaceuticals Pvt. Dated Ltd., 20-03-2014 1.5KM, Mangour, Saharanpur Road, Roorkee, Haridwar, Uttarakhand-247658 13 RINOSTAT + B. No. 2832006, Disintegration Drugs Control RDTL, TABLETS D/Mfg. Oct, 2012, Report No. Department, Guwahati D/Exp. Sep, 2015, 08912/2013- Nagaland Mfg. By. 14 M/s Innova Cap Tab, Dated Jharmajri, Baddi-173205 21-03-201414 MEBENDAZOL B. No. MB125, Disintegration Drugs Control RDTL, E TABLETS D/Mfg. Oct, 2012, Report No. Department, Guwahati D/Exp. Sep, 2014, 08914/2013- Arunachal Mfg. By. 14 Pradesh M/s Danish Laboratories, Dated 13, Dadabhai Naoroji Marg, 21-03-2014 Ujjain-456001 15 RAB-GENTA B. No. RGT-01, BET Test Drugs Control RDTL, INJECTIONS D/Mfg. Jul, 2013 , Report No. Department, Guwahati D/Exp. Jun, 2015, 08931/2013- Arunachal Mfg. By. 14 Pradesh M/s Argon Remedies Pvt. Ltd., Dated Saverkhera Moradabad Road, 24-03-2014 Kashipur, Uttarakhand-244713 16 GEENOR – 400 B. No. NR4-182, Disintegration Drugs Control RDTL, TABLETS D/Mfg. Jul, 2012, , Assay Department, Guwahati D/Exp. Jun, 2015, Report No. Assam Mfg. By. 08982/2013- M/s Ghanshyam 14 Pharmaceuticals, Dated D-14, Rani Industrial Area, 27-03-2014 Kamrup-781131 17 MATIPHYLLINE B. No.MTT01-34, Assay Drugs Control RDTL, TABLETS D/Mfg. Jul, 2013, Report No. Department, Guwahati D/Exp. Jun, 2015, 08983/2013- Assam Mfg. By. 14 M/s Unicure(India) Pvt. Ltd., Dated C-22,Sector-3, Noida-201301 27-03-2014 18 MATIPHYLLINE B. No.MTT29-71 , Assay Drugs Control RDTL, TABLETS D/Mfg. Jul, 2012 , Report No. Department, Guwahati D/Exp. Jun, 2014, 08984/2013- Assam Mfg. By. 14 M/s Unicure(India) Pvt. Ltd., Dated C-22,Sector-3, Noida-201301 27-03-2014 19 ERYTHROMYCI B. No. EE002, Disintegration Drugs Control RDTL, N ESTOLATE D/Mfg. Jul , 2013, Report No. Department, Guwahati TABLETS D/Exp. Jun, 2015, 08995/2013- Assam Mfg. By. 14 M/s Hecatomb Laboratory Pvt. Dated Ltd., 27-03-2014 Bagharbari, Panjabari, Guwahati-781037 20 ERYTHROMYCI B. No. EE007, Disintegration Drugs Control RDTL, N ESTOLATE D/Mfg. Jul , 2013, Report No. Department, Guwahati TABLETS D/Exp. Jun, 2015, 08993/2013- Assam Mfg. By. 14 M/s Hecatomb Laboratory Pvt. Dated Ltd., 27-03-2014 Bagharbari, Panjabari, Guwahati-781037 21 OMEPRAZOLE B. No. OZC01-22A, Dissolution Drugs Control RDTL, CAPSULES D/Mfg. Jul, 2013, Report No. Department, Guwahati D/Exp. Jun, 2015, 09010/2013- Assam Mfg. By. 14 M/s Unicure(India) Pvt. Ltd., Dated C-22,Sector-3, Noida-201301 28-03-201422 RIDNOR-400 B. No. TNF-1215, Dissolution Drugs Control RDTL, TABLETS D/Mfg. Jan, 2013, Report No. Department, Guwahati D/Exp. Dec, 2015, 09048/2013- Arunachal Mfg. By. 14 Pradesh M/s Ridley Life Sciences Pvt. Dated Ltd., 28-03-2014 D-1651, DSIDC Industrial Complex, Narela-110040, Delhi 23 Diclofenac Batch No – IE-313 Uniformity of CDSCO, Sub RDTL, Sodium & D/Mfg. – MAY/2013 Weight Zone, Chandigarh Nimesulide D/Exp. – APR./2015 Chandigarh Report No. Capsules Mfd. By- M/s TORQUE (TOREX) PHARMACEUTICALS RDTL/461/13 PVT.LTD., -14 13B-14, EPIP-1, Jharmajri- 173205. 24 Serratiopeptidase Batch No – SN-355 Disintegration CDSCO, RDTL, & Diclofenac D/Mfg. – APR./2013 Test North Zone, Chandigarh Potassium Tablets D/Exp. – MAR./2015 Report No. Ghaziabad Mfd. By- RDTL/519/13 M/s Proceed Formulations, -14 17, Ind.Area, Village Morthikri, Ramgarh, Derabassi Road, Derabassi (Pb.) 25 Nicardia Retard B. No.: AKG2015 Dissolution CDSCO, East CDL, Kolkata 20 Tablets Mfg dt: 12/2012 32-8/2013-SS/ Zone, Kolkata (Nifedipine Exp dt: 11/2015 DCA(E)- Sustained Release Mfd by: M/s. J.B. Chemicals 158/5361 Tablets IP 20 mg) & Pharmaceuticals Ltd., 128/1, Dt. GIDC, Ankleshwar 393 002. 28.03.2014 26 Sterodin Injection B. No.: 167/13 pH, CDSCO, North CDL, Kolkata Mfg dt: 01/2013 Particulate Zone, Exp dt: 12/2014 Matter, Ghaziabad Mfd by: M/s. Union Drug Assay, Company Ltd., 182, Rai Description Bahadur Road, Kolkata 34 32-1/2013-SS/ DCA(N)- 66/5371 Dt. 21.03.2014 27 Sterodin Injection B. No.: 167/13 pH, CDSCO, North CDL, Kolkata Mfg dt: 01/2013 Particulate Zone, Exp dt: 12/2014 Matter, Ghaziabad Mfd by: M/s. Union Drug Assay, Company Ltd., 182, Rai Description Bahadur Road, Kolkata 34 32-1/2013-SS/ DCA(N)- 68/5372 Dt. 21.03.201428 Eprin 150 Tablets B. No.: NE0172011I Dissolution CDSCO, West CDL, Kolkata (Aspirin Delayed Zone, Mumbai Mfg dt: 04/2012 32-9/2013-SS/ Release Tablets USP) Exp dt: 03/2014 DCA(W)- 108/5364 Mfd by: M/s. Elder Pharmaceuticals Ltd., D-220, Dt. TTC Industrial Area, Navi 20.03.2014 Mumbai 400706 29 Glimepiride B. No.: GM 1202 Dissolution CDSCO, East CDL, Kolkata Tablets IP 1mg Mfg dt: 11/2012 32-8/2013-SS/ Zone, Kolkata Exp dt: 10/2014 DCA(E)- Mfd by: M/s. LA-Chemico 21/5273 Pvt. Ltd., Taki Road, Dt. Kadambagachi, Barasat 743 19.03.2014 221. 30 Donica-SR B. No.: 020711 Dissolution CDSCO, East CDL, Kolkata Capsules Zone, Kolkata Mfg dt: 07/2011 32-8/2013-SS/ (Indomethacin Extended Release Exp dt: 03/2014 DCA(E)- Capsules USP) 55/5238 Mfd by: M/s. BDH Industries Ltd., Akurli Road, Mumbai Dt. 400 101. 14.03.2014 31 Sterodin Injection B. No.: 152/12 pH, CDSCO, North CDL, Kolkata Mfg dt: 08/2012 Particulate Zone, Exp dt: 07/2014 Matter, Ghaziabad Mfd by: M/s. Union Drug Sterility, Company Ltd., 182, Rai Assay, Bahadur Road, Kolkata 34 Description 32-1/2013-SS/ DCA(N)- 65/5202 Dt. 12.03.2014 32 Multiple B. No.: 21F-005 Assay of CDSCO, North CDL, Kolkata Electrolytes & Mfg dt: 02/2012 Potassium Zone, Dextrose Injection Exp dt: 01/2015 32-1/2013-SS/ Ghaziabad IP Type I, 500 ml Mfd by: M/s. PDPL Parenteral DCA(N)- Drugs (India) Ltd., Vill- 44/5185 Asarawad, Dudhia, Indore Dt. 453331 11.03.2014 33 Orapaste Oral B. No.: A00512 Assay CDSCO, East CDL, Kolkata Paste Mfg dt: 10/2012 32-8/2013-SS/ Zone, Kolkata (Triamcinolone Exp dt: 03/2014 DCA(E)- Acetonide Oral Mfd by: M/s. Palsons Drugs 203/5173 Paste) Pvt. Ltd., E7-92/New, Biren Dt. Roy Road (West), Kolkata 10.03.2014 700061CDSCO, South CDTL, Zone, Chennai Chennai TDT-13012 DICLOFENAC Sample No:PD/TN/47/2013 SODIUM D/M: MAY.2013 TABLETS IP 50 D/E: APR.2015 Disintegration 34 mg Cassel Research Laboratories Test (ENTERIC Pvt Ltd., COATED Plot No.54, SIDCO Industrial TABLETS) Estate , Thirumudivakkam, Chennai- 600 044.

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