Recalls / Class III
Class IIID-1516-2019
Product
Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) and b) 28 count bottles (NDC 69238-1605-08)
- Affected lot / code info
- a) Lot # BA10619A, b) Lot # BA10619B, exp. date 07/2020
Why it was recalled
Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergonovine Maleate tablets
Recalling firm
- Firm
- Amneal Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 50 Horseblock Rd, N/A, Brookhaven, New York 11719-9509
Distribution
- Quantity
- a) 2,256 bottles; b) 240 bottles
- Distribution pattern
- Product was distributed to three major distributors who may have further distributed the product nationwide.
Timeline
- Recall initiated
- 2019-07-18
- FDA classified
- 2019-07-24
- Posted by FDA
- 2019-07-31
- Terminated
- 2020-04-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1516-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.