Drug recall D-0894-2022
Product
Losartan Pot/HCTZ 50/12.5 mg 90 Tabs NDC 72189-297-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540
Reason for recall
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Lots and codes
Lots: 19NO2108 Exp. 1/31/25; 19NO2114 Exp. 1/31/25; 22NO2126 Exp. 1/31/25
Recall details
- Recalling firm
- Direct Rx, Dawsonville, GA
- Quantity
- 6 bottles
- Distribution
- FL
- Type
- Voluntary: Firm initiated
- Recall initiated
- May 11, 2022
- Terminated
- December 2, 2022
Related products
- Losartan Potassium and Hydrochlorothiazide – drug information
- NDC 72189-297 Losartan Potassium And Hydrochlorothiazide · Hydrochlorothiazide 12.5 mg/1; Losartan Potassium 50 mg/1 · DirectRx