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.
Reported: December 5, 2018 Initiated: November 1, 2018 #D-0359-2019
Product Description
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.
Details
- Recalling Firm
- Sandoz, Inc
- Units Affected
- 170 HDPE bottles
- Distribution
- OH, PR
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Sandoz, Inc. Units affected: 170 HDPE bottles.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 5, 2018. Severity: Moderate. Recall number: D-0359-2019.
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