FDAFDA · Food and drugs·Recall number D-1027-2018
Valsartan 80 mg tablets, 90-count bottles (NDC 63629-6922-2), 60-count bottles ( 63629-6922-3), 28-count bottles (63629-6922-4), 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
- Manufacturer
- Bryant Ranch Prepack Inc.
- Distributor
- Product was distributed in HI, IN, and FL.
- Lot
- Lot # 111158; Exp. 02/19
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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