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Recall Observatory FDA recall evidence

Drug product

Losartan Potassium Tablets, USP, 50 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816. 90 film coated tablets NDC 64380-934-05 1000 film coated tablets NDC 64380-934-08

D-0973-2022

May 18, 2022

Class II

Product summary

Firm
Strides Pharma Inc.
Event
Event 90229
Status
Terminated
Classification
Class II
Quantity
381456 bottles
Official record key
drug-enforcement:D-0973-2022

Official wording

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

Code information: NDC 64380-934-05 Lot 7901146A, 7901147A, 7901148A & 7901149A, Exp Date Sep-22; Lot 7901279A, 7901280A, 7901281A, 7901282A, 7901283A & 7901284A, Exp Date Nov-22; Lot 7901359A, 7901360A & 7901361A, Exp Date Dec-22; Lot 7901362A, 7901406A, 7901407A, 7901408A & 7901409A, Exp Date Jan-23. 64380-934-08 Lot 7901008A & 7901009A, Exp Date Jun-22; Lot 7901150A & 7901151A, Exp Date Sep-22; Lot 7901285B, 7901286B, 7901287A, 7901288A, 7901289A, 7901290A, 7901291A, 7901292A, 7901293A & 7901294A, Exp Date Nov-22.

Distribution pattern: Nationwide

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