Drug product
Esomeprazole Magnesium Delayed-Release Capsules, USP 20 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 42292-009-16
D-0860-2022
Product summary
- Event
- Event 89930
- Status
- Terminated
- Classification
- Class II
- Quantity
- 555 cartons
- Official record key
drug-enforcement:D-0860-2022
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 #: 3112743, Exp. Date 4/30/2023; 3112582, Exp. Date 3/31/2023; 3110438, 3111708, 3111120, Exp. Date 7/31/2022
Distribution pattern: Nationwide within USA
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications