Class II Recall

RemedyRepack Inc.

Product
Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repackaged NDC# 70518-3231-00
Reason
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Classification
Class II
Status
Terminated
Lot
Lot # B1377711-100521, exp. date 10/31/2022 B1412137-102621, exp. date 10/31/2022
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
RemedyRepack Inc. — Class II Recall | MedicineWatch US