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Recall Observatory FDA recall evidence

Drug product

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

D-0887-2022

May 02, 2022

Class II

Product summary

Firm
RemedyRepack Inc.
Event
Event 90127
Status
Terminated
Classification
Class II
Quantity
30 bottles/90 count = 2,700 tablets
Official record key
drug-enforcement:D-0887-2022

Official wording

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

Code information: Lot # B1364261-092721, exp. date 09/30/2022 B1377667-100521, exp. date 10/31/2022 B1412576-102621, exp. date 10/31/2022 B1436925-111321, exp. date 11/30/2022

Distribution pattern: Product was distributed to FL, SC and VA

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