Reported May 8, 2019 · Ongoing
Losartan Potassium Tablets USP 50 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-517-15 Manufactured for: AvKARE Inc.…
AVKARE 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: AVKARE Inc. · 615 N 1st St · Pulaski, TN · 38478-2403
Is this the product you have?
- Losartan Potassium Tablets USP 50 mg 50 tablets (5x10) Unit Dose Rx
- Only NDC 50268-517-15 Manufactured forAvKARE Inc. Pulaski, TN 38478
- Lot codes and dates
- Lot20121 Exp. 6/30/2019
- Amount recalled
- 1438 cartons (71,900 tablets)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
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 of 0.96 parts per million.
This product could cause temporary or reversible health problems — stop using it.
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