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Date: 2021-04-14 Category: Not Applicable State: Union Government Country: India

Drug Alert list for month of March 2021

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

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Executive Summary & Key Takeaways

Gazette Overview

  • This gazette notification lists drugs, medical devices, and cosmetics declared as Not of Standard Quality, Spurious, Adulterated, or Misbranded for March 2021.
  • A total of 1572 samples were tested.
  • 1553 samples were declared as of Standard Quality.
  • 18 samples were declared as Not of Standard Quality, with an additional 1 sample from a survey.
  • 0 samples were declared as Spurious.
  • 0 samples were declared as Misbranded.

Key Changes - Not of Standard Quality Products

  • Operation Theatre Gauze (Gauze Swabs B.P. 80) Batch No.: 08 failed due to Warp Threads per 10 cm.
  • Surgicom (Cotton Gauze Pad) (Absorbent Gauze – BP Type 13) Batch No.: 1023/20 failed due to Threads per stated length for the absorbent cotton gauze (13 light).
  • Combine Dressing Pad B.P. 1980 Batch No.: CD012 failed due to Sterility.
  • CORSAVE-10 (Rosuvastatin Calcium Tablets I.P. 10 mg) Batch No.: 19SGLT011 failed due to Related Substances.
  • XTER-250 (Terbinafine Tablets I.P. 250 mg) Batch No.: 419-1282 failed due to Dissolution.
  • CHYMOCIP (Trypsin & Chymotrypsin Tablets) Batch No.: G19CHP004 failed due to Assay of Trypsin and Chymotrypsin.
  • Paracetamol Tablets IP 650 mg (Febrex -650) Batch No.: FAP1D07 failed due to Dissolution.
  • Ondansetron Tablets IP 4 mg Batch No.: T13104 failed due to Dissolution.
  • MOXEL-250 (Amoxycillin Capsules IP 250 mg) Batch No.: VBC-19I25 failed due to Assay.
  • ERA CARE HAND SANITIZER Batch No.: LTLAP035 failed Identification.
  • VEL-SAFE HAND SANITIZER Batch No.: VH-1505 failed due to Assay of Glycerol and Hydrogen Peroxide.
  • Ofloxacin and Ornidazole Suspension (INTRACARE R.T.U. SUSPENSION) Batch No.: UIU-22120 failed due to Assay of Ofloxacin and Ornidazole.
  • LEEGRA 120 Tablets (Fexofenndine Hydrochloride Tablets IP 120 mg) Batch No.: OLST – 035 failed due to Dissolution.
  • HAVLOC INSTANT HAND SANITIZER GEL Batch No.: BR0402 failed due to Assay of Ethyl Alcohol.
  • HAVLOC INSTANT HAND SANITIZER LIQUID Batch No.: BR0401 failed due to Assay of Ethyl Alcohol.
  • HAVLOC INSTANT HAND SANITIZER GEL Batch No.: BR0412 failed due to Assay of Ethyl Alcohol.
  • i Clean Hand Sanitizer (Isopropyl Alcohol) Batch No.: IC328 failed due to Assay of Isopropyl Alcohol. Manufacturer not stated on label.
  • i Clean Hand Sanitizer (Isopropyl Alcohol) Batch No.: 1220 failed due to Assay of Isopropyl Alcohol. Manufacturer not stated on label.

Impact Analysis

Manufacturers

  • Manufacturers of i Clean Hand Sanitizer need to include their name on the label.

Consumers

  • Consumers should be advised to discontinue use of the products and report any adverse events.

Distributors and Retailers

  • They should verify the authenticity and quality of products from these manufacturers before future procurement.

Regulatory Authorities (CDSCO, State Drug Control)

  • Increased surveillance and testing of pharmaceutical products and medical devices are necessary.

Our Company

  • Communicate this information to our sales and marketing teams to ensure they are aware of the affected products and manufacturers.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organisation, the national regulatory body for pharmaceuticals and medical devices in India. CDL: Central Drugs Laboratory RDTL: Regional Drugs Testing Laboratory Drugs and Cosmetics Act: The primary legislation governing the quality control and regulation of drugs, cosmetics, and medical devices in India. (Implied) Operation Theatre Gauze: Medical device used in surgical procedures. Surgicom (Cotton Gauze Pad): Medical device used for wound care. Combine Dressing Pad B.P. 1980: Medical device used for wound care. CORSAVE-10 (Rosuvastatin Calcium Tablets I.P. 10 mg): Pharmaceutical drug used to lower cholesterol. XTER-250 (Terbinafine Tablets I.P. 250 mg): Pharmaceutical drug used to treat fungal infections. CHYMOCIP (Trypsin & Chymotrypsin Tablets): Pharmaceutical drug used to reduce inflammation and swelling. Paracetamol Tablets IP 650 mg (Febrex -650): Pharmaceutical drug used to relieve pain and fever. Ondansetron Tablets IP 4 mg: Pharmaceutical drug used to prevent nausea and vomiting. MOXEL-250 (Amoxycillin Capsules IP 250 mg): Pharmaceutical drug, an antibiotic used to treat bacterial infections. ERA CARE HAND SANITIZER: Hand sanitizer product. VEL-SAFE HAND SANITIZER: Hand sanitizer product. Ofloxacin and Ornidazole Suspension (INTRACARE R.T.U. SUSPENSION): Pharmaceutical drug, a combination antibiotic used to treat bacterial and protozoal infections. LEEGRA 120 Tablets (Fexofenndine Hydrochloride Tablets IP 120 mg): Pharmaceutical drug, an antihistamine used to relieve allergy symptoms. HAVLOC INSTANT HAND SANITIZER GEL: Hand sanitizer product. HAVLOC INSTANT HAND SANITIZER LIQUID: Hand sanitizer product. i Clean Hand Sanitizer (Isopropyl Alcohol): Hand sanitizer product.
Official Source Record View Original Source →
See Full Document Text
List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the Month of March-2021 Total number of samples tested 1572 Total number of samples declared as of Standard Quality 1553 Total number of samples declared as Not of Standard Quality 18+1 (Survey) Total number of samples declared as Spurious 0 Total number of samples declared as Misbranded 0 S. Name of Batch No./Date of Reason for Drawn From No. Drugs/medical Manufacture/Date of failure By device/cosmetics Expiry/Manufactured By 1. Operation Theatre B. No.: 08 (Warp) Threads CDSCO, CDL, Gauze (Gauze Swabs Mfg dt: 08/2020 per 10 cm South Kolkata Exp dt: 07/2023 Zone B.P. 80) Mfd by: M/s. Anand Chennai Product, 8/162, J – 17, Vanniyampatti Road, Sankarapandiyapuram, Chatrapatti – 626 102, Tamil Nadu. 2. Surgicom (Cotton B. No.: 1023/20 Threads per CDSCO, CDL, Gauze Pad) (Absorbent Mfg dt: 03/2020 stated length for South Kolkata Exp dt: 02/2023 Zone Gauze – BP Type 13 the absorbent Mfd by: M/s. The Ramaraju Chennai Absorbent Cotton Wool cotton gauze (13 Surgical Cotton Mills Ltd., IP) light) 2/318-2/321, Sankarankovil Road, Perumalpatti- 627 753, Tamil Nadu. 3. Combine Dressing Pad B. No.: CD012 Sterility CDSCO, CDL, B.P. 1980 Mfg dt: 11/2018 South Kolkata Exp dt: 10/2021 Zone, Mfd by: M/s. Modern Chennai Healthcare, 782/15, North Street, Chatrapatti -626102 (Via) Rajapalayam, TamilNaudu. 4. CORSAVE-10 B. No.: 19SGLT011 Related CDSCO CDL, (Rosuvastatin Calcium Mfg dt: 12/2019 Substances East Kolkata Exp dt: 11/2021 Zone Tablets I.P. 10 mg) Mfd by: M/s. Synokem Pharmaceuticals Limited, Plot No. 35-36, Sector-6A, I.I.E. (SIDCUL), Ranipur(BHEL), Haridwar -249 403, (Uttarakhand). 5. XTER-250 (Terbinafine B. No.: 419-1282 Dissolution CDSCO CDL, Tablets I.P. 250 mg) Mfg dt: 09/2019 East Kolkata Exp dt: 08/2021 Zone Mfd by: M/s. Zee Laboratories, 47, Industrial Area, Paonta Sahib – 173 025, Himachal Pradesh. 6. CHYMOCIP (Trypsin & B. No.: G19CHP004 Assay of CDSCO CDL, Chymotrypsin Tablets) Mfg dt: 06/2019 Trypsin and East Kolkata Exp dt: 05/2022 Zone Chymotrypsin Mfd by: M/s. Acme Generics LLP, Plot No. 115, HPSIDC, Industrial Area, Davni, P.O. Gurumajra, Tehsil, Nalagarh, Distt. Solan Himachal Pradesh - 174101. 7. Paracetamol Tablets IP B. No.: FAP1D07 Dissolution CDSCO, CDL, 650 mg (Febrex -650) Mfg dt: 04/2020 Visakhap Kolkata Exp dt: 03/2022 atnam Mfd by: M/s. Indoco Remedies Ltd. Mumbai – 400 098. 8. Ondansetron Tablets IP B. No.: T13104 Dissolution CDSCO, CDTL, 4 mg Mfg dt: 02/2020 Sub-Zone Mumbai Exp dt: 01/2022 Indore Mfd by: M/s. Quest Laboratories Pvt. Ltd., Plot No.45, Sector-III, Pithampur, Dist. Dhar- 454775, Madhya Pradesh. 9. MOXEL-250 B. No.: VBC-19I25 Assay CDSCO, CDTL, (Amoxycillin Capsules Mfg dt: 09/2019 West Zone Mumbai Exp dt: 08/2022 IP 250 mg) Mfd by: M/s. Venus Biosciences P. Ltd., 116, Export Promotion Industrial Park, Phase I, Jharmajri, Baddi, Dist: Solan- 173205 Himachal Pradesh. 10. ERA CARE HAND B. No.: LTLAP035 Identification Drug RDTL, SANITIZER Mfg dt: 06/2020 Control Chandigarh Exp dt: 05/2023 Department Mfd by: M/s. Nature’s Boon Himachal Ayurvedic Pharmacy PradeshPunjab-141012. 11. VEL-SAFE HAND B. No.: VH-1505 Assay of Drug RDTL, SANITIZER Mfg dt: 11/2020 Glycerol and Control Chandigarh Exp dt: 11/2022 Hydrogen Department Mfd by: M/s. VELNEX Peroxide Himachal MEDICARE 344-A, Pradesh HSIIDC, SAHA (AMBALA) Haryana-133104. 12. Ofloxacin and B. No.: UIU-22120 Assay of Drug RDTL, Ornidazole Suspension Mfg dt: 06/2020 Ofloxacin Control Chandigarh Exp dt: 05/2022 (INTRACARE R.T.U. and Department Mfd by: M/s. Senate SUSPENSION) Ornidazole Jammu & Laboratories, 252, 252, Kashmir Sisona, Bhagwanpur, Roorkee-247661 Uttarakhand. 13. LEEGRA 120 Tablets B. No.: OLST – 035 Dissolution CDSCO CDTL, (Fexofenndine Mfg dt: 02/2020 Hyderabad Chennai Hydrochloride Tablets Exp dt: 01/2022 Zone Mfd by: M/s. Oaksun Life IP 120 mg) Sciences, Plot No. 36, 37, 38, 46 & 47, Chengicherla (V), Medipally (M), Medchal-Malkjigiri (Dist.) T.S.500 092 Telangana. 14. HAVLOC INSTANT B. No.: BR0402 Assay of Ethyl CDSCO, CDTL, HAND SANITIZER GEL Mfg dt: 04/2020 Alcohol South Zone, Chennai Exp dt: 18 months from the date of Mfg Mfd by: M/s. BRP Industry Pvt. Ltd., No. 42/2, First Floor, Govindan Street, Ayyavoo Colony, Aminjikarai, Chennai, TamilNadu – 600029. 15. HAVLOC INSTANT B. No.: BR0401 Assay of Ethyl CDSCO, CDTL, HAND SANITIZER Mfg dt: 04/2020 Alcohol South Zone, Chennai Exp dt: 18 months from LIQUID the date of Mfg Mfd by: M/s. BRP Industry Pvt. Ltd., No. 42/2, First Floor, Govindan Street, Ayyavoo Colony, Aminjikarai, Chennai, TamilNadu – 600029.16. HAVLOC INSTANT B. No.: BR0412 Assay of Ethyl CDSCO, CDTL, HAND SANITIZER GEL Mfg dt: 04/2020 Alcohol South Zone, Chennai Exp dt: 18 months from the date of Mfg Mfd by: M/s. BRP Industry Pvt. Ltd., No. 42/2, first Floor, Govindan Street, Ayyavoo Colony, Aminjikarai, Chennai, TamilNadu – 600029. 17. i Clean Hand Sanitizer B. No.: IC328 Assay of CDSCO, CDTL, (Isopropyl Alcohol) Mfg dt: 03/2020 Isopropyl South Zone, Chennai Exp dt: 24 Months. from Alcohol Date of Mfg Mfd by: Not Stated on the lable. 18. i Clean Hand Sanitizer B. No.: 1220 Assay of CDSCO, CDTL, (Isopropyl Alcohol) Mfg dt: 12/2020 Isopropyl South Zone, Chennai Exp dt: 24 Months from Alcohol Date of Mfg Mfd by: Not Stated on the lable.

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