Recalls / Class II
Class IID-0477-2024
Product
Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bridgewater, NJ 08807, NDC # 69238-1605-2.
- Brand name
- Methylergonovine Maleate
- Generic name
- Methylergonovine
- Active ingredient
- Methylergonovine Maleate
- Route
- Oral
- NDC
- 69238-1605
- FDA application
- ANDA211483
- Affected lot / code info
- Lot #: BJ01922A, exp. date 03/2024
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Amneal Pharmaceuticals of New York, LLC
- Manufacturer
- Amneal Pharmaceuticals NY LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 50 Horseblock Rd, Brookhaven, New York 11719-9509
Distribution
- Quantity
- 2784 bottles
- Distribution pattern
- US Nationwide.
Timeline
- Recall initiated
- 2024-03-25
- FDA classified
- 2024-04-29
- Posted by FDA
- 2024-05-08
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0477-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.