Drug recall D-0971-2022
Product
Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 a) 30 Tabs NDC 72189-167-30; b) 90 Tabs NDC 72189-167-90
Reason for recall
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Lots and codes
a) 30-count bottles- Lot: 11MY2103 Exp. 11/30/22 Lot: 05JA2106 Exp. 6/30/22 b) 90-count bottles- Lot: 20MY2115 Exp. 11/30/22 Lot: 22JU2118 Exp. 12/31/22 Lot: 29JY2113 Exp. 12/31/22 Lot: 13SE2113 Exp. 2/28/23 Lot: 05JA2106 Exp. 6/30/22
Recall details
- Recalling firm
- Direct Rx, Dawsonville, GA
- Quantity
- 81 bottles
- Distribution
- AL, GA, FL, LA
- Type
- Voluntary: Firm initiated
- Recall initiated
- May 5, 2022
- Terminated
- October 5, 2023
Related products
- Losartan Potassium and Hydrochlorothiazide – drug information
- NDC 72189-167 Losartan Potassium And Hydrochlorothiazide · Losartan Potassium 100 mg/1; Hydrochlorothiazide 12.5 mg/1 · Direct_Rx
- NDC 72189-139 Losartan Potassium And Hydrochlorothiazide · Hydrochlorothiazide 25 mg/1; Losartan Potassium 100 mg/1 · Direct_Rx
- NDC 72189-012 Losartan Potassium And Hydrochlorothiazide · Losartan Potassium 50 mg/1; Hydrochlorothiazide 12.5 mg/1 · Direct_Rx
- NDC 72189-098 Losartan Potassium And Hydrochlorothiazide · Losartan Potassium 100 mg/1; Hydrochlorothiazide 12.5 mg/1 · Direct_Rx
- NDC 72189-129 Losartan Potassium And Hydrochlorothiazide · Hydrochlorothiazide 12.5 mg/1; Losartan Potassium 50 mg/1 · Direct_Rx