FDA-Drug2022-06-01Class II
Losartan HCTZ 100/12.5 mg, 90 count bottles NDC# 70518-2564-00 Repackaged NDC Original NDC # 68180-0216-09
RemedyRepack Inc.
Hazard
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Sold states
Product was distributed to FL, SC and VA
Affected count
30 bottles/90 count = 2,700 tablets
Manufactured in
625 Kolter Dr Ste 4, Indiana, PA, United States
Products
Losartan HCTZ 100/12.5 mg, 90 count bottles NDC# 70518-2564-00 Repackaged NDC Original NDC # 68180-0216-09
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0887-2022Don't want to check this manually?
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