Drug product
Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-363-15
D-0091-2023
Product summary
- Firm
- AVKARE LLC
- Event
- Event 91390
- Status
- Completed
- Classification
- Class II
- Quantity
- 1237 cartons
- Official record key
drug-enforcement:D-0091-2023
Official wording
Reason: Failed impurities/degradation specifications: Out of specification for unknown impurities.
Code information: Lot#: 43313, 43342, Exp 12/2023
Distribution pattern: USA Nationwide
Derived failure modes
-
Potency or specification failure
Out of specification