Product Safety Recalls

Product Recall Tracker

LOSARTAN POTASSIUM Recall D-0972-2022

Description: Losartan Potassium Tablets, USP 25 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 64380-933-05 1000 film coated tablets NDC 64380-933-08

LOSARTAN POTASSIUM Recall D-0972-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0972-2022
Event ID90229
BrandLOSARTAN POTASSIUM
Generic NameLOSARTAN POTASSIUM
ManufacturerLOSARTAN POTASSIUM
Original Package?1
Active SubstanceLOSARTAN POTASSIUM
Drug RouteORAL
DistributionNationwide
Quantity200407 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
Similar To

© 2022 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied.
Recall.report is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.