Product Safety Recalls

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LOSARTAN POTASSIUM Recall D-0973-2022

Description: 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

LOSARTAN POTASSIUM Recall D-0973-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0973-2022
Event ID90229
BrandLOSARTAN POTASSIUM
Generic NameLOSARTAN POTASSIUM
ManufacturerLOSARTAN POTASSIUM
Original Package?1
Active SubstanceLOSARTAN POTASSIUM
Drug RouteORAL
DistributionNationwide
Quantity381456 bottles
Recall ReasonCGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Drug ClassificationClass II
Drug Code Info20220608
Product NDC64380-933 64380-934 64380-935
Drug UPC0364380935056 0364380933083 0364380935087
Recall Initiation Date20220516
Report Date20220608
Classification Date20220528
Address2 Tower Center Blvd Ste 1102
East Brunswick, NJ 08816-1100
United States
Recalling FirmStrides Pharma Inc.
Unique Ingredient Identifier3ST302B24A
Drug Application NumberANDA090382
Structured Product Labeling (SPL ID)9bbc4a81-d023-4e75-a771-52af48b21cac
Structured Product Labeling (SPL Set ID)a8817f22-8478-49b9-8354-ab27ca222c6b
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