Reported Dec 5, 2018 · Ongoing
Sandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 1000-count bottles, Rx Only, Finished Drug…
Sandoz, 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: Sandoz, Inc · 506 Carnegie Ctr Ste 400 · Princeton, NJ · 08540-6243
Is this the product you have?
- Sandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 1000-count bottles, Rx Only
- Finished Drug Product Manufactured by
Lek Pharmaceuticals d.d. SI-1526 LjubljanaSovenia for Sandoz IncPrincetonNJ 08540NDC 0781-5207-10
- Lot codes and dates
Lot #: JB8912Exp. 06/2020
- Amount recalled
- 170 HDPE bottles
Where it was sold
Why it was recalled
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
This product could cause temporary or reversible health problems — stop using it.
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