Why it was recalled
Failed Dissolution Specifications
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.
Lot numbers, UPCs & expiration codes
Lot #: BJ01922A, exp. date 03/2024
Where it was sold
US Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0477-2024
- Classification
- Class II
- Status
- Completed
- Recall initiated
- Mar 25, 2024
- FDA report date
- May 8, 2024
- Quantity
- 2784 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amneal Pharmaceuticals of New York, LLC
Original FDA data
Every field from FDA enforcement report D-0477-2024, exactly as published.
Show all FDA fields
- City
- Brookhaven
- State
- NY
- Status
- Completed
- Country
- United States
- Event ID
- 94286
- Address
- 50 Horseblock Rd
- Code information
- Lot #: BJ01922A, exp. date 03/2024
- Postal code
- 11719-9509
- Report date
- May 8, 2024
- Product type
- Drugs
- Recall number
- D-0477-2024
- Classification
- Class II
- Recalling firm
- Amneal Pharmaceuticals of New York, LLC
- Product quantity
- 2784 bottles
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- US Nationwide.
- Recall initiation date
- Mar 25, 2024
- Initial firm notification
- Letter
- Center classification date
- Apr 29, 2024