Reported Mar 27, 2019 · Terminated
Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only…
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 and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes
- Rx Only Manufactured forAvKARE Inc. Pulaski, TN 38478 --- NDC 50268-513-15
- Lot codes and dates
- Lot19454 Exp. 04/30/2019
- Amount recalled
- N/A
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
This product could cause temporary or reversible health problems — stop using it.
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