FDAFDA · Food and drugs·Recall number D-1029-2018
Valsartan 320 mg tablets, 90-count bottles ( NDC 71335-0567-2), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.
Published August 8, 2018 · Recall initiated: July 27, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- VALSARTAN
- Manufacturer
- Bryant Ranch Prepack Inc.
- Distributor
- Product was distributed in HI, IN, and FL.
- Lot
- Lot # 120879; Exp 10/19
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.