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Recall Observatory FDA recall evidence

Drug product

Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repackaged NDC# 70518-3231-00

D-0885-2022

May 04, 2022

Class II

Product summary

Firm
RemedyRepack Inc.
Event
Event 90134
Status
Terminated
Classification
Class II
Quantity
22 bottles/90 count each
Official record key
drug-enforcement:D-0885-2022

Official wording

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

Code information: Lot # B1377711-100521, exp. date 10/31/2022 B1412137-102621, exp. date 10/31/2022

Distribution pattern: Recalled product was distributed to Florida.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    AZIDO Impurity
  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations