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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

AvKARE Glycopyrrolate Tablets Recalled for Unknown Impurities

Agency Publication Date: December 28, 2022
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Summary

AVKARE LLC has recalled 1,237 cartons of AvKARE brand Glycopyrrolate Tablets, USP (1 mg), because the tablets failed to meet approved quality standards for unknown impurities. These prescription tablets, dispensed in unit-dose cartons, were distributed nationwide to pharmacies. No injuries or illnesses have been reported to date in connection with this recall.

Risk

The medication was found to contain levels of unknown impurities or degradation products that exceed approved safety and quality specifications. While no incidents have occurred, these impurities could potentially impact the effectiveness or safety of the drug over time.

What You Should Do

  1. The recalled products are AvKARE brand Glycopyrrolate Tablets, USP (1 mg), sold in 50-tablet (5x10) unit-dose cartons with NDC number 50268-363-15.
  2. Check the carton and individual tablet packaging for lot numbers 43313 or 43342 with an expiration date of 12/2023.
  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 AVKARE LLC for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

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: Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose cartonby AvKARE
Variants: 1 mg, Tablet, Unit Dose
Lot Numbers:
43313 (Exp 12/2023)
43342 (Exp 12/2023)
NDC:
50268-363-15

Manufactured for: AvKARE Pulaski, TN 38478; Rx Only

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91390
Status: Resolved
Manufacturer: AVKARE LLC
Sold By: pharmacies
Manufactured In: United States
Units Affected: 1237 cartons
Distributed To: Nationwide

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.