Class II
Ongoing
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.
- Company
- Sandoz Inc
- Recall Initiated
- November 1, 2018
- Posted
- December 5, 2018
- Recall Number
- D-0359-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 170 HDPE bottles
- Firm Location
- Princeton, NJ, United States
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.
Distribution
OH, PR
Lot / Code Info
Lot #: JB8912; Exp. 06/2020
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