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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Trandolapril and Verapamil ER Tablets Recalled for Subpotency

Agency Publication Date: August 22, 2023
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Summary

Glenmark Pharmaceuticals Inc., USA is recalling 1,200 bottles of Trandolapril and Verapamil Hydrochloride Extended-Release Tablets (2 mg / 180 mg) because the medication was found to be subpotent during a quality test. This means the tablets may contain less of the active ingredient than specified, which could reduce the medication's effectiveness. The recall affects 100-count bottles from batch number 19224744.

Risk

Subpotent medication may not provide the full prescribed dose of the blood pressure treatment. This can lead to poorly controlled blood pressure and associated cardiovascular risks. No injuries or adverse events have been reported to date.

What You Should Do

  1. The recalled products are 100-count bottles of Trandolapril and Verapamil Hydrochloride Extended-Release Tablets (2 mg / 180 mg) labeled with NDC 68462-295-01 and Batch # 19224744.
  2. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Glenmark Pharmaceuticals Inc., USA for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Trandolapril and Verapamil Hydrochloride Extended-Release Tablets (2 mg / 180 mg), 100-count Bottle
Variants: 2 mg / 180 mg, 100-count Bottle, Extended-Release, Rx only
Lot Numbers:
19224744
NDC:
68462-295-01

Recall #: D-1095-2023; Out of Specification for Assay Test at the 3-month time point.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92859
Status: Active
Manufacturer: Glenmark Pharmaceuticals Inc., USA
Manufactured In: India, United States
Units Affected: 1,200 bottles
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.