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Date: 2021-03-03 Category: Not Applicable State: Union Government Country: India

Drug Alert list for month of Feb 2021

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 issues a drug alert regarding Clopitab (Clopidogrel tablets IP), batch number J901640, manufactured by M/s Lupin Limited.
  • The alert was issued based on information/clarification received from M/s Lupin Limited.

Key Changes

  • The drug alert pertains to Clopitab (Clopidogrel tablets IP) with batch number J901640.
  • The Manufacture Date (M/D) is 10/2019 and Expiry Date (E/D) is 03/2021.
  • The manufacturer is allegedly M/s Lupin Limited, EPIP Kartholi, SIDCO Industrial Complex, Bari Brahmana, Dist. –Samba, Jammu (J&K) – 181133.

Impact Analysis

Patients

  • Patients should be informed about the drug alert and potential risks associated with the affected batch.

Lupin Limited

  • Lupin Limited may need to recall the affected batch from the market.

Pharmacies and Distributors

  • Pharmacies and distributors should cooperate with Lupin Limited and regulatory authorities in the recall process, if initiated.

Regulatory Authorities

  • Regulatory authorities should take appropriate action based on the findings of the investigation, which may include penalties or sanctions.

Key Entities Referenced

Clopitab (Clopidogrel tablets IP): A pharmaceutical product, specifically Clopidogrel tablets IP, which is subject to a drug alert. M/s Lupin Limited: The alleged manufacturer of the affected batch of Clopitab (Clopidogrel tablets IP). The address provided is EPIP Kartholi, SIDCO Industrial Complex, Bari Brahmana, Dist. –Samba, Jammu (J&K) – 181133. Batch No. J901640: The specific batch number of Clopitab (Clopidogrel tablets IP) that is subject to the drug alert.
Official Source Record View Original Source →
See Full Document Text
Drug Alert S. No. Name of Drugs/medical Batch No./Date of Remark device/cosmetics Manufacture/Date of Expiry/Manufactured By 1. Clopitab (Clopidogrel Batch no. J901640, As informed/clarified by tablets IP) M/D: 10/2019 M/s Lupin E/D: 03/2021 Limited. Alleged to be mfd by: M/s Lupin Limited, EPIP Kartholi, SIDCO Industrial Complex, Bari Brahmana, Dist. –Samba, Jammu (J&K) – 181133.

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