Product Safety Recalls

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LOSARTAN POTASSIUM Recall D-1161-2022

Description: 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

LOSARTAN POTASSIUM Recall D-1161-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1161-2022
Event ID90383
BrandLOSARTAN POTASSIUM
Generic NameLOSARTAN POTASSIUM
ManufacturerLOSARTAN POTASSIUM
Active SubstanceLOSARTAN POTASSIUM
Drug RouteORAL
DistributionNationwide
Quantity1441 bottles
Recall ReasonCGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Drug ClassificationClass II
Drug Code Info20220706
Product NDC72789-163 72789-164 72789-165
Drug UPC0372789163901 0372789164908 0372789165905
Recall Initiation Date20220606
Report Date20220706
Classification Date20220627
Address727 N Ann Arbor Ave
Oklahoma City, OK 73127-5822
United States
Recalling FirmPD-Rx Pharmaceuticals, Inc.
Initial Notification Letter
Unique Ingredient Identifier3ST302B24A
Drug Application NumberANDA090382
Structured Product Labeling (SPL ID)d57ec0fb-1969-1d80-e053-2995a90a4e48
Structured Product Labeling (SPL Set ID)372ba4ad-26ca-4675-8475-4b664fbecba9
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