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Class II: temporary or reversible health riskOngoing

Aurolife Pharma Glycopyrrolate Tablets Recall

Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Phar…

Aurolife Pharma, LLC · Dayton, NJ

Risk level
Class II
Reported by FDA
Dec 28, 2022
Recall ID
D-0087-2023
Check your lot numberHow we source this data

Summary

Aurolife Pharma recalled Glycopyrrolate Tablets starting Dec 16, 2022. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0087-2023 on Dec 28, 2022. Reason: Failed Impurities/Degradation Specifications. Status: Ongoing.

Why it was recalled

Failed Impurities/Degradation Specifications

Product description

Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01

Lot numbers, UPCs & expiration codes

Lots: 01422002A1, Expiry: 12/2023; 01421078A3, Expiry: 09/2023

Where it was sold

Nationwide in the USA and Puerto Rico.

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0087-2023
Classification
Class II
Status
Ongoing
Recall initiated
Dec 16, 2022
FDA report date
Dec 28, 2022
Quantity
7344 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Aurolife Pharma, LLC

Original FDA data

Every field from FDA enforcement report D-0087-2023, exactly as published.

Show all FDA fields
City
Dayton
State
NJ
Status
Ongoing
Country
United States
Event ID
91319
Address
2400 US Highway 130
Code information
Lots: 01422002A1, Expiry: 12/2023; 01421078A3, Expiry: 09/2023
Postal code
08810-1519
Report date
Dec 28, 2022
Product type
Drugs
Recall number
D-0087-2023
Classification
Class II
Recalling firm
Aurolife Pharma, LLC
Product quantity
7344 bottles
Reason for recall
Failed Impurities/Degradation Specifications
Voluntary / mandated
Voluntary: Firm initiated
Product description
Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01
Distribution pattern
Nationwide in the USA and Puerto Rico.
Recall initiation date
Dec 16, 2022
Center classification date
Dec 22, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0087-2023, published Dec 28, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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