Drug product
Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg, 30, 90 & 1000 count NDC # 33342-052-07, NDC #33342-052-10 & NDC # 33342-052-44, Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
D-1164-2022
Product summary
- Event
- Event 90426
- Status
- Terminated
- Classification
- Class II
- Quantity
- 84/1000 count bottles
- Official record key
drug-enforcement:D-1164-2022
Official wording
Reason: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Code information: Lot # BLM2114A, exp. date 07/2023
Distribution pattern: Product was distributed nationwide.
Derived failure modes
-
Foreign material or chemical contamination
AZIDO Impurity
-
Manufacturing or process control
CGMP Deviations