FDA-Drug2022-06-01Class II
Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repackaged NDC# 70518-3231-00
RemedyRepack Inc.
Hazard
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Sold states
Recalled product was distributed to Florida.
Affected count
22 bottles/90 count each
Manufactured in
625 Kolter Dr Ste 4, Indiana, PA, United States
Products
Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repackaged NDC# 70518-3231-00
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0885-2022Don't want to check this manually?
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