D-1516-2019 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 31, 2019
- Initiation Date
- July 18, 2019
- Termination Date
- April 22, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 2,256 bottles; b) 240 bottles
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
Distribution Pattern
Product was distributed to three major distributors who may have further distributed the product nationwide.
Code Information
a) Lot # BA10619A, b) Lot # BA10619B, exp. date 07/2020