Why it was recalled
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Product description
Valsartan/HCTZ 160/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867,
Lot numbers, UPCs & expiration codes
Lot # T11443; Exp. 02/28/2019
Where it was sold
Distributed to three customers in Fl and CA
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-1038-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 30, 2018
- FDA report date
- Aug 15, 2018
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- NuCare Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-1038-2018, exactly as published.
Show all FDA fields
- City
- Orange
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 80701
- Address
- 622 W Katella Ave
- Code information
- Lot # T11443; Exp. 02/28/2019
- Postal code
- 92867-4608
- Report date
- Aug 15, 2018
- Product type
- Drugs
- Recall number
- D-1038-2018
- Classification
- Class II
- Recalling firm
- NuCare Pharmaceuticals Inc
- Termination date
- Apr 22, 2021
- Reason for recall
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Valsartan/HCTZ 160/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867,
- Distribution pattern
- Distributed to three customers in Fl and CA
- Recall initiation date
- Jul 30, 2018
- Initial firm notification
- Letter
- Center classification date
- Aug 3, 2018