Recalls / Class II
Class IID-0359-2019
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.
- Affected lot / code info
- Lot #: JB8912; Exp. 06/2020
Why it was 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.
Recalling firm
- Firm
- Sandoz, Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 506 Carnegie Ctr Ste 400, N/A, Princeton, New Jersey 08540-6243
Distribution
- Quantity
- 170 HDPE bottles
- Distribution pattern
- OH, PR
Timeline
- Recall initiated
- 2018-11-01
- FDA classified
- 2019-01-14
- Posted by FDA
- 2018-12-05
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0359-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.