Why it was recalled
Presence of Foreign Substance: Complaint for pieces of glass discovered in a sealed bottle which came from equipment within the packaging room.
Product description
Glycopyrrolate Tablets, USP, 1 mg, 100-count bottle, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, NDC 13107-014-01.
Lot numbers, UPCs & expiration codes
Lot: 01421008A1, Exp 03/2023
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-0736-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 17, 2022
- FDA report date
- Apr 6, 2022
- Quantity
- 4080 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aurolife Pharma, LLC
Original FDA data
Every field from FDA enforcement report D-0736-2022, exactly as published.
Show all FDA fields
- City
- Dayton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 89869
- Address
- 2400 US Highway 130
- Code information
- Lot: 01421008A1, Exp 03/2023
- Postal code
- 08810-1519
- Report date
- Apr 6, 2022
- Product type
- Drugs
- Recall number
- D-0736-2022
- Classification
- Class II
- Recalling firm
- Aurolife Pharma, LLC
- Product quantity
- 4080 bottles
- Termination date
- Mar 25, 2024
- Reason for recall
- Presence of Foreign Substance: Complaint for pieces of glass discovered in a sealed bottle which came from equipment within the packaging room.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Glycopyrrolate Tablets, USP, 1 mg, 100-count bottle, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, NDC 13107-014-01.
- Distribution pattern
- Nationwide in the USA and Puerto Rico
- Recall initiation date
- Mar 17, 2022
- Initial firm notification
- Letter
- Center classification date
- Mar 30, 2022