Amneal Pharmaceuticals, Inc. recalls Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) and b) 28 count bottles (NDC 69238-1605-08)
Recalled July 31, 2019 · FDA recall D-1516-2019 · Amneal Pharmaceuticals
Hazard
Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergonovine Maleate tablets · FDA Class III
Units
a) 2,256 bottles; b) 240 bottles
Sold at
Product was distributed to three major distributors who may have further distributed the product nationwide.
Description
Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergonovine Maleate tablets
Product
Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) and b) 28 count bottles (NDC 69238-1605-08)
Manufacturer(s)
Amneal Pharmaceuticals, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →