FDAFDA · Food and drugs·Recall number D-0359-2019
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 Ljubljana,Sovenia for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5207-10.
Published December 5, 2018 · Recall initiated: November 1, 2018
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sandoz, Inc
- Distributor
- OH, PR
- Lot
- Lot #: JB8912; Exp. 06/2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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