Class II
Terminated
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.
This recall has been terminated (originally issued August 8, 2018).
- Company
- Bryant Ranch Prepack, Inc.
- Recall Initiated
- July 27, 2018
- Posted
- August 8, 2018
- Recall Number
- D-1028-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 990 tablets
- Firm Location
- Burbank, CA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Distribution
Product was distributed in HI, IN, and FL.
Lot / Code Info
Lot # 114319; Exp. 10/18 Lot # 109004; Exp. 12/18
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