Reported May 22, 2019 · Terminated
Losartan Potassium Tab. USP 50mg, a) 30 count bottle (NDC 68788-0048-03) and b) 90 count bottle (NDC 68788-0048-09), Rx…
Preferred Pharmaceuticals, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Preferred Pharmaceuticals, Inc · 1250 N Lakeview Ave Ste O · Anaheim, CA · 92807-1801
Is this the product you have?
- 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
- MfgTorrent Pharma Inc., Basking Ridge, NJ
- Lot codes and dates
- a) 30 tabletslot A1818G batch 01181807 exp 3/2020
- b) 90 tabletslot L0517L batch 12051712 exp 3/2020
Where it was sold
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
This product could cause temporary or reversible health problems — stop using it.
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