Drug product

Losartan Potassium Tablets, USP 25 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 72789-163-90 UPC 3 72789 16390 1

D-1161-2022

June 06, 2022

Class II

Product summary

Firm: PD-Rx Pharmaceuticals, Inc.
Event: Event 90383
Status: Terminated
Classification: Class II
Quantity: 1441 bottles
Official record key: drug-enforcement:D-1161-2022

Official wording

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

Code information: Lots: D21C18 Exp. 09/30/22; E21A28 Exp. 09/30/22; E21C04 Exp. 09/30/22; E21D59 Exp. 09/30/22; G21B65 Exp. 09/30/22; H21A12 Exp. 09/30/22; H21D42 Exp. 09/30/22; K21D19 Exp. 10/31/22; A22A73 Exp. 10/31/22

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