FDA-Drug2019-04-17Class II
Losartan 50mg Tablet, 30 count each blister card.
RemedyRepack Inc.
Hazard
CGMP Deviations; Detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) - N-Methylnitrosobutyric acid (NMBA).
Sold states
Product was distributed to one sole customer, Miami, FL.
Affected count
33 blister cards of 30 = 990 tablets
Manufactured in
625 Kolter Dr Ste 4, N/A, Indiana, PA, United States
Products
Losartan 50mg Tablet, 30 count each blister card.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1081-2019Don't want to check this manually?
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