Drug 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.
D-0788-2022
Product summary
- Event
- Event 89968
- Status
- Terminated
- Classification
- Class II
- Quantity
- 433/30 count blister cards, 33/60 count blister cards
- Official record key
drug-enforcement:D-0788-2022
Official wording
Reason: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Code information: Lot # B1467803-120621, exp. date 06/30/2022 Lot # J0585793-121721, exp. date 12/31/2022
Distribution pattern: Product was distributed to customers in AK and PA.
Derived failure modes
-
Foreign material or chemical contamination
AZIDO Impurity
-
Manufacturing or process control
CGMP Deviations