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Recall Observatory FDA recall evidence

Drug product

Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet, Rx Only (HDPE 90cc Bottles in cardboard trays) MFG Torrent Pharma LTD, Indrad, India 38272, NDC #70518-1220-0

D-1146-2018

August 20, 2018

Class II

Product summary

Firm
RemedyRepack Inc.
Event
Event 80891
Status
Terminated
Classification
Class II
Quantity
3 bottles of 90 tablets (270 tablets overall)
Official record key
drug-enforcement:D-1146-2018

Official wording

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

Code information: 70518-1220-0; Lot #: B0476653-080218; Exp. Date: 08/2019

Distribution pattern: 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