Recalls / Class II
Class IID-1281-2019
Product
Losartan Potassium Tab. USP 50mg, a) 30 count bottle (NDC 68788-0048-03) and b) 90 count bottle (NDC 68788-0048-09), Rx only, Preferred Pharmaceuticals, Inc., Anaheim, CA, Mfg: Torrent Pharma Inc., Basking Ridge, NJ
- Affected lot / code info
- a) 30 tablets: lot A1818G batch 01181807 exp 3/2020; b) 90 tablets: lot L0517L batch 12051712 exp 3/2020
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 at the manufacturer
Recalling firm
- Firm
- Preferred Pharmaceuticals, Inc
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 1250 N Lakeview Ave Ste O, Anaheim, California 92807-1801
Distribution
- Distribution pattern
- CA, GA, IN. No DOD/VA accounts. No foreign accounts.
Timeline
- Recall initiated
- 2019-04-30
- FDA classified
- 2019-05-16
- Posted by FDA
- 2019-05-22
- Terminated
- 2023-04-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1281-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.