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Recall Observatory FDA recall evidence

Drug product

Losartan Potassium Tablets, USP 100 mg, 90 Tablets bottles, Rx Only, Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, OK 73127 Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram-603 110, Tamilnadu, India NDC 72789-165-90 UPC 3 72789 16590 5

D-1163-2022

June 06, 2022

Class II

Product summary

Firm
PD-Rx Pharmaceuticals, Inc.
Event
Event 90383
Status
Terminated
Classification
Class II
Quantity
1320 bottles
Official record key
drug-enforcement:D-1163-2022

Official wording

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

Code information: Lots: G21C26 Exp. 07/31/22; H21B96 Exp. 07/31/22; I21B39 Exp. 07/31/22; I21C44 Exp. 07/31/22; D21F35 Exp. 10/31/22; E21A66 Exp. 10/31/22; E21C72 Exp. 10/31/22; E21F01 Exp. 10/31/22; F21C15 Exp. 10/31/22; F21E19 Exp. 10/31/22; G21B14 Exp. 10/31/22; K21A61 Exp. 11/30/22; L21A45 Exp. 11/30/22

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