Drug product
Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) and b) 28 count bottles (NDC 69238-1605-08)
D-1516-2019
Product summary
- Event
- Event 83206
- Status
- Terminated
- Classification
- Class III
- Quantity
- a) 2,256 bottles; b) 240 bottles
- Official record key
drug-enforcement:D-1516-2019
Official wording
Reason: Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergonovine Maleate tablets
Code information: a) Lot # BA10619A, b) Lot # BA10619B, exp. date 07/2020
Distribution pattern: Product was distributed to three major distributors who may have further distributed the product nationwide.
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablet