Why it was recalled
Failed impurities/degradation specifications: Out of specification for unknown impurities.
Product description
Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-363-15
Lot numbers, UPCs & expiration codes
Lot#: 43313, 43342, Exp 12/2023
Where it was sold
USA Nationwide
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-0091-2023
- Classification
- Class II
- Status
- Completed
- Recall initiated
- Dec 22, 2022
- FDA report date
- Jan 4, 2023
- Quantity
- 1237 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AVKARE LLC
Original FDA data
Every field from FDA enforcement report D-0091-2023, exactly as published.
Show all FDA fields
- City
- Pulaski
- State
- TN
- Status
- Completed
- Country
- United States
- Event ID
- 91390
- Address
- 615 N 1st St
- Code information
- Lot#: 43313, 43342, Exp 12/2023
- Postal code
- 38478-2403
- Report date
- Jan 4, 2023
- Product type
- Drugs
- Recall number
- D-0091-2023
- Classification
- Class II
- Recalling firm
- AVKARE LLC
- Product quantity
- 1237 cartons
- Reason for recall
- Failed impurities/degradation specifications: Out of specification for unknown impurities.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-363-15
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Dec 22, 2022
- Initial firm notification
- Letter
- Center classification date
- Dec 28, 2022