Drug product
Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01
D-0877-2023
Product summary
- Event
- Event 92379
- Status
- Terminated
- Classification
- Class III
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0877-2023
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot #: 01421038A1, Exp. Date 05/2023
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications