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.
Reported: May 4, 2022 Initiated: April 6, 2022 #D-0788-2022
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.
Reason for Recall
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Details
- Recalling Firm
- RemedyRepack Inc.
- Units Affected
- 433/30 count blister cards, 33/60 count blister cards
- Distribution
- Product was distributed to customers in AK and PA.
- Location
- Indiana, PA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by RemedyRepack Inc.. Units affected: 433/30 count blister cards, 33/60 count blister cards.
Why was this product recalled? ▼
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 4, 2022. Severity: Moderate. Recall number: D-0788-2022.
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