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Recall Observatory FDA recall evidence

Drug product

LOSARTAN POTASSIUM TABLETS, USP, 25 mg, 90-count bottle (NDC: 13668-113-90), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda

D-0503-2019

December 20, 2018

Class II

Product summary

Firm
Torrent Pharma Inc.
Event
Event 81838
Status
Ongoing
Classification
Class II
Quantity
43,416 bottles
Official record key
drug-enforcement:D-0503-2019

Official wording

Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Code information: Count, lots, expiry: [90-count bottle] Lot 4O49C013, exp 09/2019

Distribution pattern: Nationwide USA and Puerto Rico

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    impurity, N-nitrosodimethylamine (NDEA
  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations