Recalls / Class II
Class IID-0788-2022
Product
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.
- Affected lot / code info
- Lot # B1467803-120621, exp. date 06/30/2022 Lot # J0585793-121721, exp. date 12/31/2022
Why it was recalled
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Recalling firm
- Firm
- RemedyRepack Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 625 Kolter Dr Ste 4, Indiana, Pennsylvania 15701-3571
Distribution
- Quantity
- 433/30 count blister cards, 33/60 count blister cards
- Distribution pattern
- Product was distributed to customers in AK and PA.
Timeline
- Recall initiated
- 2022-04-06
- FDA classified
- 2022-04-26
- Posted by FDA
- 2022-05-04
- Terminated
- 2022-05-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0788-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.