Why it was recalled
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Product description
Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/12.5 MG Tablets, 90-count bottle, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-314-09
Lot numbers, UPCs & expiration codes
All lots within expiry.
Where it was sold
United States
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-0975-2018
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jul 13, 2018
- FDA report date
- Aug 1, 2018
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Prinston Pharmaceutical Inc
Original FDA data
Every field from FDA enforcement report D-0975-2018, exactly as published.
Show all FDA fields
- City
- Cranbury
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 80525
- Address
- 2002 Eastpark Blvd
- Code information
- All lots within expiry.
- Postal code
- 08512-3514
- Report date
- Aug 1, 2018
- Product type
- Drugs
- Recall number
- D-0975-2018
- Classification
- Class II
- Recalling firm
- Prinston Pharmaceutical Inc
- Reason for recall
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/12.5 MG Tablets, 90-count bottle, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-314-09
- Distribution pattern
- United States
- Recall initiation date
- Jul 13, 2018
- Initial firm notification
- Letter
- Center classification date
- Jul 20, 2018