Recalls / Class II
Class IID-1028-2018
Product
Valsartan 320 mg tablets, 30-count bottles ( NDC 63629-6905-1), 90-count bottles (NDC 63629-6905-2), 28-count bottles (NDC 6362-96905-3), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.
- Affected lot / code info
- Lot # 114319; Exp. 10/18 Lot # 109004; Exp. 12/18
Why it was recalled
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recalling firm
- Firm
- Bryant Ranch Prepack Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1919 N Victory Pl, N/A, Burbank, California 91504-3425
Distribution
- Quantity
- 990 tablets
- Distribution pattern
- Product was distributed in HI, IN, and FL.
Timeline
- Recall initiated
- 2018-07-27
- FDA classified
- 2018-08-02
- Posted by FDA
- 2018-08-08
- Terminated
- 2021-04-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1028-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.