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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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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Rasagiline Mesylate Tablets Recalled for Foreign Metallic Specks

Agency Publication Date: January 17, 2023
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Summary

Ascend Laboratories, LLC is recalling 12,192 bottles of Rasagiline Mesylate 1 mg tablets because of a report of black spots and shiny metallic specks found on the tablets. Rasagiline Mesylate is a prescription medication used to treat Parkinson's disease. The recall affects 30-count HDPE bottles manufactured by Alkem Laboratories in India and distributed across 19 states and Puerto Rico. While one consumer complaint has been received, no injuries have been reported to date. If you have this medication, you should consult your pharmacist or doctor regarding replacement.

Risk

The presence of foreign metallic specks on oral tablets poses a potential risk of irritation or injury to the digestive tract if ingested. Although no injuries have been reported, the presence of an unknown metallic substance in medication is a serious quality and safety concern.

What You Should Do

  1. This recall affects Rasagiline Mesylate Tablets 1 mg sold in 30-count bottles under NDC 67877-260-30. The affected product is from lot number 22140903 with an expiration date of December 2024.
  2. Check your prescription bottle label for the NDC code 67877-260-30 and look for lot number 22140903 to determine if your medication is part of the recall.
  3. 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 Ascend Laboratories, LLC for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions or to report adverse events.

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: Rasagiline Mesylate Tablets 1 mg (30-count bottle)
Variants: 1 mg, Tablet
Lot Numbers:
22140903 (Exp. Dec. 2024)
NDC:
67877-260-30

Distributed in 30 tablets in HDPE bottle; Rx only; Manufactured by Alkem Laboratories Ltd., India.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91385
Status: Resolved
Manufacturer: Ascend Laboratories, LLC
Sold By: Pharmacies
Manufactured In: India, United States
Units Affected: 12192 bottles
Distributed To: California, Florida, Georgia, Illinois, Kentucky, Louisiana, Michigan, Minnesota, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Tennessee, Texas, Washington, Wisconsin, Puerto Rico

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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.