Drug product
Losartan Pot/HCTZ 100/25 mg 90 Tabs NDC 72189-289-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540
D-0895-2022
Product summary
- Firm
- Direct Rx
- Event
- Event 90200
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11 bottles
- Official record key
drug-enforcement:D-0895-2022
Official wording
Reason: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Code information: Lots: 08NO2102 Exp. 1/31/25; 17NO2118 Exp. 1/31/25; 18NO2123 Exp. 1/31/25; 25OC2114 Exp. 1/31/25; 22NO2105 Exp. 1/31/25
Distribution pattern: FL
Derived failure modes
-
Foreign material or chemical contamination
AZIDO Impurity
-
Manufacturing or process control
CGMP Deviations