Medications & Supplements/Prescription Drugs

Aurolife Pharma Glycopyrrolate Tablets Recalled for Glass Contamination

Agency Publication Date: March 30, 2022

Summary

Aurolife Pharma, LLC is recalling 4,080 bottles of Glycopyrrolate Tablets (1 mg), a prescription medication used to treat stomach ulcers. The recall was issued after a complaint revealed pieces of glass inside a sealed bottle, which likely originated from equipment used in the packaging room. If you take this medication, please contact your healthcare provider or pharmacist for guidance on your treatment.

Risk

Ingesting glass fragments in a tablet can cause physical trauma, irritation, or cuts to the mouth, throat, or digestive tract. No injuries or incidents have been reported to date in connection with this recall.

What You Should Do

This recall affects 100-count bottles of Glycopyrrolate Tablets, USP, 1 mg, labeled with NDC 13107-014-01, Lot 01421008A1, and an expiration date of March 2023.
Identify the product by checking the National Drug Code (NDC) and lot number printed on the bottle label. The product was distributed by Aurobindo Pharma USA, Inc.
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 Aurobindo Pharma USA, Inc. 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)

Variants: 1 mg, 100-count bottle, Rx Only

Lot Numbers:

01421008A1 (Exp 03/2023)

NDC:

13107-014-01

Recall #: D-0736-2022; Distributed by Aurobindo Pharma USA, Inc.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89869

Status: Resolved

Manufacturer: Aurolife Pharma, LLC

Sold By: Pharmacies nationwide; Aurobindo Pharma USA, Inc.

Manufactured In: United States

Units Affected: 4080 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 affects 100-count bottles of Glycopyrrolate Tablets, USP, 1 mg, labeled with NDC 13107-014-01, Lot 01421008A1, and an expiration date of March 2023.

Identify the product by checking the National Drug Code (NDC) and lot number printed on the bottle label. The product was distributed by Aurobindo Pharma USA, Inc.

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 Aurobindo Pharma USA, Inc. for further instructions.

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