Drug product
Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01
D-0087-2023
Product summary
- Event
- Event 91319
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 7344 bottles
- Official record key
drug-enforcement:D-0087-2023
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lots: 01422002A1, Expiry: 12/2023; 01421078A3, Expiry: 09/2023
Distribution pattern: Nationwide in the USA and Puerto Rico.
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications