D-0788-2022 Class II Terminated
FDA drug recall D-0788-2022 was initiated by RemedyRepack Inc. on Apr 6, 2022 and is designated Class II. Reason for recall: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits. The recall status is terminated (terminated May 27, 2022). Affected quantity: 433/30 count blister cards, 33/60 count blister cards.
Recall Details
- Product Type
- Drugs
- Report Date
- May 4, 2022
- Initiation Date
- Apr 6, 2022
- Termination Date
- May 27, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 433/30 count blister cards, 33/60 count blister cards
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.
Reason for Recall
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Distribution Pattern
Product was distributed to customers in AK and PA.
Code Information
Lot # B1467803-120621, exp. date 06/30/2022 Lot # J0585793-121721, exp. date 12/31/2022
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0788-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026