Drug product
Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5 mg, Pkg Size: 30, NDC: 68788-7758-03.
D-0892-2022
Product summary
- Event
- Event 90148
- Status
- Terminated
- Classification
- Class II
- Quantity
- 47 Bottles of 30 Tabs (K1721E); 35 Bottles of 30 Tabs (H3021Q).
- Official record key
drug-enforcement:D-0892-2022
Official wording
Reason: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Code information: Lot: K1721E, EXP: 4/30/2023, NDC: 68788-7758-03; Lot: H3021Q, EXP: 2/28/2023, NDC: 68788-7758-03.
Distribution pattern: Within the U.S in FL and CA.
Derived failure modes
-
Foreign material or chemical contamination
AZIDO Impurity
-
Manufacturing or process control
CGMP Deviations