FDA recall D-0477-2024
Amneal Pharmaceuticals of New York, LLC · Class II · 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.
Reason for recall
Failed Dissolution Specifications
Distribution
US Nationwide.
Key facts
- Status
- Completed
- Initiation date
- 2024-03-25
- Report date
- 2024-05-08
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Brookhaven, NY, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0477-2024