Recalls / Class II
Class IID-1029-2018
Product
Valsartan 320 mg tablets, 90-count bottles ( NDC 71335-0567-2), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.
- Brand name
- Valsartan
- Generic name
- Valsartan
- Active ingredient
- Valsartan
- Route
- Oral
- NDC
- 71335-0567
- FDA application
- ANDA204821
- Affected lot / code info
- Lot # 120879; Exp 10/19
Why it was recalled
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recalling firm
- Firm
- Bryant Ranch Prepack Inc.
- Manufacturer
- Bryant Ranch Prepack
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1919 N Victory Pl, N/A, Burbank, California 91504-3425
Distribution
- Quantity
- 90 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-1029-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.