Losartan Potassium Tablet
FDA Recall NDC 70518-3282
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Losartan Potassium (NDC 70518-3282). A significant event, classified as Class II, was initiated on Apr 06, 2022 by Remedyrepack Inc.. The reported reason for this action was: "CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
April 2022 Class II Recall: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Recall Number
Class II Terminated
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Apr 06, 2022
May 04, 2022
433/30 count blister cards, 33/60 count blister cards
Recall Profile & Regulatory Data
Event ID
89968
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
RemedyRepack Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to customers in AK and PA.
Termination Date
May 27, 2022
Product 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.
Batch or Lot Expiration Information
Lot# B1467803-120621, exp. date 06/30/2022
Lot# J0585793-121721, exp. date 12/31/2022
Affected Packages Involved in this Recall
70518-3282-0Product
70518-3282-1Product
70518-3282-2Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
