Medications & Supplements/Prescription Drugs

Aurobindo Glycopyrrolate Tablets Recalled for Impurity Specifications

Agency Publication Date: December 22, 2022

Summary

Aurolife Pharma, LLC is recalling 7,344 bottles of Glycopyrrolate Tablets (1 mg), which are used to treat peptic ulcers. The recall was issued because the tablets failed to meet specific quality standards for impurities and degradation during stability testing. Using medication that has degraded or contains higher than allowed levels of impurities may cause the drug to be less effective or lead to unexpected side effects.

Risk

The drug failed stability testing for impurities and degradation. This means the medication may break down faster than intended, potentially reducing its therapeutic benefit or exposing patients to unknown degradation products.

What You Should Do

This recall involves 100-count bottles of Glycopyrrolate Tablets, USP, 1 mg (NDC 13107-014-01) distributed by Aurobindo Pharma USA, Inc.
Identify if your medication is affected by checking the lot number and expiration date on the bottle label for lot 01422002A1 (Expiry 12/2023) or lot 01421078A3 (Expiry 09/2023).
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 Aurolife Pharma, LLC for further instructions.
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:

Option 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

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 (100 tablets)

Variants: 1 mg, 100 tablets, Rx Only

Lot Numbers:

01422002A1 (Exp 12/2023)

01421078A3 (Exp 09/2023)

NDC:

13107-014-01

Distributed by Aurobindo Pharma USA, Inc.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91319

Status: Active

Manufacturer: Aurolife Pharma, LLC

Sold By: Aurobindo Pharma USA, Inc.; Pharmacies

Manufactured In: United States

Units Affected: 7344 bottles

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 · 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.

Summary

What You Should Do

This recall involves 100-count bottles of Glycopyrrolate Tablets, USP, 1 mg (NDC 13107-014-01) distributed by Aurobindo Pharma USA, Inc.

Identify if your medication is affected by checking the lot number and expiration date on the bottle label for lot 01422002A1 (Expiry 12/2023) or lot 01421078A3 (Expiry 09/2023).

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 Aurolife Pharma, LLC for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.