Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) and b) 28 count bottles (NDC 69238-1605-08)
Reported: July 31, 2019 Initiated: July 18, 2019 #D-1516-2019
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)
Reason for Recall
Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergonovine Maleate tablets
Details
- Recalling Firm
- Amneal Pharmaceuticals, Inc.
- Units Affected
- a) 2,256 bottles; b) 240 bottles
- Distribution
- Product was distributed to three major distributors who may have further distributed the product nationwide.
- Location
- Brookhaven, NY
Frequently Asked Questions
What product 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). Recalled by Amneal Pharmaceuticals, Inc.. Units affected: a) 2,256 bottles; b) 240 bottles.
Why was this product recalled? ▼
Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergonovine Maleate tablets
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 31, 2019. Severity: Low. Recall number: D-1516-2019.
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