Why it was recalled
Failed Tablet/Capsule Specifications: confirmed customer complaint of thicker and heavier tablets in bottle.
Product description
Valsartan Tablets, USP, 160 mg, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd, Xunqiao, Linhai, Zhejiang 317024, China; Distributed by: Solco Healthcare US, LLC, Cranbury, NJ 08512, USA; NDC 43547-369-09.
Lot numbers, UPCs & expiration codes
Lot #: 343B17025, Exp 03/31/19
Where it was sold
Nationwide in the USA and Puerto Rico
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-0209-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 29, 2017
- FDA report date
- Jan 17, 2018
- Quantity
- 21,987 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Prinston Pharmaceutical Inc
Original FDA data
Every field from FDA enforcement report D-0209-2018, exactly as published.
Show all FDA fields
- City
- Cranbury
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 78651
- Address
- 2002 Eastpark Blvd
- Code information
- Lot #: 343B17025, Exp 03/31/19
- Postal code
- 08512-3514
- Report date
- Jan 17, 2018
- Product type
- Drugs
- Recall number
- D-0209-2018
- Classification
- Class II
- Recalling firm
- Prinston Pharmaceutical Inc
- Product quantity
- 21,987 bottles
- Termination date
- Aug 16, 2019
- Reason for recall
- Failed Tablet/Capsule Specifications: confirmed customer complaint of thicker and heavier tablets in bottle.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Valsartan Tablets, USP, 160 mg, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd, Xunqiao, Linhai, Zhejiang 317024, China; Distributed by: Solco Healthcare US, LLC, Cranbury, NJ 08512, USA; NDC 43547-369-09.
- Distribution pattern
- Nationwide in the USA and Puerto Rico
- Recall initiation date
- Nov 29, 2017
- Initial firm notification
- Letter
- Center classification date
- Jan 8, 2018