Drug product
Esomeprazole Magnesium Delayed-Release Capsules, USP 40 mg, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 Capsules each per carton), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC 42292-010-16
D-0861-2022
Product summary
- Event
- Event 89930
- Status
- Terminated
- Classification
- Class II
- Quantity
- 885 cartons
- Official record key
drug-enforcement:D-0861-2022
Official wording
Reason: Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
Code information: Lot #: 3110437, 3111409, 3110785, Exp. Date 7/31/2022; 3112173, Exp. Date 11/30/2022
Distribution pattern: Nationwide within USA
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications