FDA recall D-1516-2019

Amneal Pharmaceuticals, Inc. · Class III · 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)

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.

Key facts

Status
Terminated
Initiation date
2019-07-18
Report date
2019-07-31
Termination date
2020-04-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Brookhaven, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1516-2019