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Date: 2022-11-23 Category: Not Applicable State: Union Government Country: India

Drug Alert list for month of October 2022 (Revised)

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

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Executive Summary & Key Takeaways

What it means

  • The gazette notification is a list of drugs, medical devices, and cosmetics declared as Not of Standard Quality, Spurious, Adulterated, or Misbranded for the month of October 2022 (Revised).

Key Changes

  • Montek® LC Tablets (Montelukast Sodium & Levocetirizine Hydrochloride Tablets IP), Batch No.: SIC1932, manufactured by M/s. Sun pharma laboratories ltd. is declared as spurious.
  • The reason for failure is due to identification and assay of Montelukast.
  • The drug was drawn by Drug RDTL Control Department Assam from Guwahati.
  • The manufacturer, M/s. Sun Pharma Laboratories Ltd., has confirmed that the impugned batch was not manufactured by them.
  • Control samples are stated to be complying with the specifications.

Impact Analysis

Stakeholders

  • Pharmacies and Retailers: Must ensure that the specific batch of Montek® LC tablets (Batch No.: SIC1932) is removed from shelves to prevent further distribution.

Suggested Action Items

  • Patients: If you have consumed Montek® LC tablets from batch SIC1932, consult a healthcare professional immediately.

Key Entities Referenced

Montek® LC (Montelukast Sodium & Levocetirizine Hydrochloride Tablets IP): A pharmaceutical product declared as spurious in the gazette notification. M/s. Sun Pharma Laboratories Ltd.: The manufacturer named on the label of the spurious drug, who has disclaimed its manufacture. Drug RDTL Control Department Assam: The drug control department that identified and reported the spurious drug.
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 October 2022 (Revised) S. Name of the Product Manufactured Reason for Drawn By From Remarks No. Drugs Details By Failure 8 Montek® LC B. No.: Allegedly Identificatio Drug RDTL The (Montelukast SIC1932 manufactured n and Control Guwahati manufacturer (as Sodium & A Mfg dt: by: M/s. Sun Assay of Department per label i.e. Levocetirizine 08/2021 pharma Montelukast Assam M/s. Sun Hydrochloride Exp dt: laboratories Pharma Tablets IP 01/2024 ltd. Plot No. Laboratories 107-108, Ltd.) has Namli Block, confirmed that P.O. Ranipool, the impugned East Sikkim- batch is not 737135. manufactured by (as per label them. Claim) Control samples are stated to be complying with the specifications. Hence, the drug in question is stated to be spurious.

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