Class III
Terminated
Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) and b) 28 count bottles (NDC 69238-1605-08)
- Company
- Amneal Pharmaceuticals, Inc.
- Recall Initiated
- July 18, 2019
- Posted
- July 31, 2019
- Recall Number
- D-1516-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- a) 2,256 bottles; b) 240 bottles
- Firm Location
- Brookhaven, NY, United States
Reason for Recall
Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergonovine Maleate tablets
Distribution
Product was distributed to three major distributors who may have further distributed the product nationwide.
Lot / Code Info
a) Lot # BA10619A, b) Lot # BA10619B, exp. date 07/2020
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