Drug product
Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bridgewater, NJ 08807, NDC # 69238-1605-2.
D-0477-2024
Product summary
- Event
- Event 94286
- Status
- Completed
- Classification
- Class II
- Quantity
- 2784 bottles
- Official record key
drug-enforcement:D-0477-2024
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot #: BJ01922A, exp. date 03/2024
Distribution pattern: US Nationwide.
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications