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Recall Observatory FDA recall evidence

Drug product

Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets, HDPE 90 cc bottles in cardboard trays Original NDC 13668-0325-30 Repackaged NDC 70518-1220-00

D-0093-2019

August 24, 2018

Class II

Product summary

Firm
RemedyRepack Inc.
Event
Event 81395
Status
Terminated
Classification
Class II
Quantity
2 bottles of 90 tablets (180 tablets)
Official record key
drug-enforcement:D-0093-2019

Official wording

Reason: CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.

Code information: Lot # B0438903-052118 70518-1220-00

Distribution pattern: Product was distributed to a medical facility in South Carolina

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    NDMA, a possible impurity
  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations