RemedyRepack Inc. recalls Losartan 50mg Tablet, 30 count each blister card.
Recalled April 17, 2019 · FDA recall D-1081-2019 · RemedyRepack
Hazard
CGMP Deviations; Detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) - N-Methylnitrosobutyric acid (NMBA). · FDA Class II
Units
33 blister cards of 30 = 990 tablets
Sold at
Product was distributed to one sole customer, Miami, FL.
Description
CGMP Deviations; Detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) - N-Methylnitrosobutyric acid (NMBA).
Product
Losartan 50mg Tablet, 30 count each blister card.
Manufacturer(s)
RemedyRepack Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →