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)
- Recall date
- July 18, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1516-2019
- FDA classification
- Class III
- Brand / firm
- Amneal Pharmaceuticals, Inc.
- Sold / distributed
- Product was distributed to three major distributors who may have further distributed the product nationwide.
Why it was recalled
Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergonovine Maleate tablets
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) and b) 28 count bottles (NDC 69238-1605-08)
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