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.

FDA recall notice · announced December 5, 2018 · Sandoz

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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.

Reason for recall

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.

Notes

Distribution: OH, PR
Lot/code information: Lot #: JB8912; Exp. 06/2020
Quantity: 170 HDPE bottles
Status: Ongoing
Products in this recall event:
- 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 (D-0359-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.