FDA-Drug2022-05-04Class II
Losartan Potassium 50 mg Tablet, a) 30-count blister card (NDC# 70518-3282-1), b) 60-count blister card (NDC: 70518-3282-0), Rx Only, MFG by: Lupin Pharma, Baltimore, MD 21202.
RemedyRepack Inc.
Hazard
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Sold states
Product was distributed to customers in AK and PA.
Affected count
433/30 count blister cards, 33/60 count blister cards
Manufactured in
625 Kolter Dr Ste 4, Indiana, PA, United States
Products
Losartan Potassium 50 mg Tablet, a) 30-count blister card (NDC# 70518-3282-1), b) 60-count blister card (NDC: 70518-3282-0), Rx Only, MFG by: Lupin Pharma, Baltimore, MD 21202.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0788-2022Don't want to check this manually?
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