Recalls / Class II
Class IID-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
- Brand name
- Losartan Potassium And Hydrochlorothiazide
- Generic name
- Losartan Potassium And Hydrochlorothiazide
- Active ingredients
- Hydrochlorothiazide, Losartan Potassium
- Route
- Oral
- NDC
- 72189-297
- FDA application
- ANDA202289
- Affected lot / code info
- Lots: 19NO2108 Exp. 1/31/25; 19NO2114 Exp. 1/31/25; 22NO2126 Exp. 1/31/25
Why it was recalled
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Recalling firm
- Firm
- Direct Rx
- Manufacturer
- DirectRx
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 94 Worldwide Dr, Dawsonville, Georgia 30534-6828
Distribution
- Quantity
- 6 bottles
- Distribution pattern
- FL
Timeline
- Recall initiated
- 2022-05-11
- FDA classified
- 2022-05-24
- Posted by FDA
- 2022-06-01
- Terminated
- 2022-12-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0894-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.