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RemedyRepack Inc. recalls Losartan HCTZ 100/12.5 mg, 90 count bottles NDC# 70518-2564-00 Repackaged NDC Original NDC # 68180-0216-09

Recalled June 1, 2022 · FDA recall D-0887-2022 · RemedyRepack

Hazard
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits. · FDA Class II
Units
30 bottles/90 count = 2,700 tablets
Sold at
Product was distributed to FL, SC and VA

Description

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.

Product
Losartan HCTZ 100/12.5 mg, 90 count bottles NDC# 70518-2564-00 Repackaged NDC Original NDC # 68180-0216-09
Manufacturer(s)
RemedyRepack Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov