Why it was recalled
Failed Impurities/Degradation Specifications
Product description
Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01
Lot numbers, UPCs & expiration codes
Lot #: 01421038A1, Exp. Date 05/2023
Where it was sold
Nationwide within the United States
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-0877-2023
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 18, 2023
- FDA report date
- Jun 28, 2023
- Recalling firm
- Aurolife Pharma, LLC
Original FDA data
Every field from FDA enforcement report D-0877-2023, exactly as published.
Show all FDA fields
- City
- Dayton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 92379
- Address
- 2400 US Highway 130
- Code information
- Lot #: 01421038A1, Exp. Date 05/2023
- Postal code
- 08810-1519
- Report date
- Jun 28, 2023
- Product type
- Drugs
- Recall number
- D-0877-2023
- Classification
- Class III
- Recalling firm
- Aurolife Pharma, LLC
- Termination date
- Aug 28, 2024
- Reason for recall
- Failed Impurities/Degradation Specifications
- Product description
- Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- May 18, 2023
- Center classification date
- Jun 20, 2023