Sandoz Losartan Potassium and Hydrochlorothiazide recall: Impurity Out of Spec
Sandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 1000-count bottles, Rx Only, Finished Drug Product Manufactured by: Lek…
Why was Sandoz Losartan Potassium and Hydrochlorothiazide 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: JB8912; Exp. 06/2020
- Product
- Sandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 1000-count bottles, Rx Only, Finished Drug Product Manufactured by: Lek…
- Recalling firm
- Sandoz, Inc
- Quantity
- 170 HDPE bottles
- Distribution
- OH, PR
- Recall date
- December 5, 2018
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)