D-0477-2024 Class II
FDA drug recall D-0477-2024 was initiated by Amneal Pharmaceuticals of New York, LLC on March 25, 2024 and is designated Class II. Reason for recall: Failed Dissolution Specifications Affected quantity: 2784 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 8, 2024
- Initiation Date
- March 25, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2784 bottles
Product Description
Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bridgewater, NJ 08807, NDC # 69238-1605-2.
Reason for Recall
Failed Dissolution Specifications
Distribution Pattern
US Nationwide.
Code Information
Lot #: BJ01922A, exp. date 03/2024