Why it was recalled
Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergonovine Maleate tablets
Product description
Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) and b) 28 count bottles (NDC 69238-1605-08)
Lot numbers, UPCs & expiration codes
a) Lot # BA10619A, b) Lot # BA10619B, exp. date 07/2020
Where it was sold
Product was distributed to three major distributors who may have further distributed the product 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-1516-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 18, 2019
- FDA report date
- Jul 31, 2019
- Quantity
- a) 2,256 bottles; b) 240 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amneal Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1516-2019, exactly as published.
Show all FDA fields
- City
- Brookhaven
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 83206
- Address
- 50 Horseblock Rd
- Code information
- a) Lot # BA10619A, b) Lot # BA10619B, exp. date 07/2020
- Postal code
- 11719-9509
- Report date
- Jul 31, 2019
- Product type
- Drugs
- Recall number
- D-1516-2019
- Classification
- Class III
- Recalling firm
- Amneal Pharmaceuticals, Inc.
- Product quantity
- a) 2,256 bottles; b) 240 bottles
- Termination date
- Apr 22, 2020
- Reason for recall
- Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergonovine Maleate tablets
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) and b) 28 count bottles (NDC 69238-1605-08)
- Distribution pattern
- Product was distributed to three major distributors who may have further distributed the product nationwide.
- Recall initiation date
- Jul 18, 2019
- Initial firm notification
- Letter
- Center classification date
- Jul 24, 2019