Recalls / Class II
Class IID-0018-2021
Product
Losartan Potassium 100 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-952-30
- Affected lot / code info
- Lot: 27AU1801 Exp. 02/28/2021
Why it was recalled
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level per manufacturer
Recalling firm
- Firm
- Direct Rx
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 94 Worldwide Dr, N/A, Dawsonville, Georgia 30534-6828
Distribution
- Quantity
- 33 bottles
- Distribution pattern
- GA
Timeline
- Recall initiated
- 2019-04-30
- FDA classified
- 2020-10-05
- Posted by FDA
- 2020-10-14
- Terminated
- 2020-12-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0018-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.