Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) and b) 28 count bottles (NDC 69238-1605-08)

FDA recall notice · announced July 31, 2019 · Amneal Pharmaceuticals

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) and b) 28 count bottles (NDC 69238-1605-08)

Reason for recall

Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergonovine Maleate tablets

Notes

Distribution: Product was distributed to three major distributors who may have further distributed the product nationwide.
Lot/code information: a) Lot # BA10619A, b) Lot # BA10619B, exp. date 07/2020
Quantity: a) 2,256 bottles; b) 240 bottles
Status: Terminated
Products in this recall event:
- Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) and b) 28 count bottles (NDC 69238-1605-08) (D-1516-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.