Product Safety Recalls

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LOSARTAN POTASSIUM Recall D-0788-2022

Description: Losartan Potassium 50 mg Tablet, a) 30-count blister card (NDC# 70518-3282-1), b) 60-count blister card (NDC: 70518-3282-0), Rx Only, MFG by: Lupin Pharma, Baltimore, MD 21202.

LOSARTAN POTASSIUM Recall D-0788-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0788-2022
Event ID89968
BrandLOSARTAN POTASSIUM
Generic NameLOSARTAN POTASSIUM
ManufacturerLOSARTAN POTASSIUM
Active SubstanceLOSARTAN POTASSIUM
Drug RouteORAL
DistributionProduct was distributed to customers in AK and PA.
Quantity433/30 count blister cards, 33/60 count blister cards
Recall ReasonCGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Drug ClassificationClass II
Drug Code Info20220504
Product NDC70518-3282
Recall Initiation Date20220406
Report Date20220504
Classification Date20220426
Address625 Kolter Dr Ste 4
Indiana, PA 15701-3571
United States
Recalling FirmRemedyRepack Inc.
Initial Notification E-Mail
Unique Ingredient Identifier3ST302B24A
Drug Application NumberANDA078232
Structured Product Labeling (SPL ID)d395b63e-8855-7da7-e053-2a95a90a1e00
Structured Product Labeling (SPL Set ID)c43e9dc6-2c8a-47d7-b40d-eb55dfe11a51
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