D-0359-2019 Class II Ongoing
FDA drug recall D-0359-2019 was initiated by Sandoz, Inc on Nov 1, 2018 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 170 HDPE bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 5, 2018
- Initiation Date
- Nov 1, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 170 HDPE bottles
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.
Distribution Pattern
OH, PR
Code Information
Lot #: JB8912; Exp. 06/2020
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0359-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026