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.
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.
Lot numbers, UPCs & expiration codes
Lot #: JB8912; Exp. 06/2020
Where it was sold
OH, PR
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0359-2019
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Nov 1, 2018
- FDA report date
- Dec 5, 2018
- Quantity
- 170 HDPE bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sandoz, Inc
Original FDA data
Every field from FDA enforcement report D-0359-2019, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 81485
- Address
- 506 Carnegie Ctr Ste 400
- Code information
- Lot #: JB8912; Exp. 06/2020
- Postal code
- 08540-6243
- Report date
- Dec 5, 2018
- Product type
- Drugs
- Recall number
- D-0359-2019
- Classification
- Class II
- Recalling firm
- Sandoz, Inc
- Product quantity
- 170 HDPE bottles
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- OH, PR
- Recall initiation date
- Nov 1, 2018
- Initial firm notification
- Letter
- Center classification date
- Jan 14, 2019