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.
Reported: August 8, 2018 Initiated: July 27, 2018 #D-1027-2018
Product Description
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.
Reason for Recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Details
- Recalling Firm
- Bryant Ranch Prepack Inc.
- Units Affected
- 690 tablets
- Distribution
- Product was distributed in HI, IN, and FL.
- Location
- Burbank, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Bryant Ranch Prepack Inc.. Units affected: 690 tablets.
Why was this product recalled? ▼
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 8, 2018. Severity: Moderate. Recall number: D-1027-2018.
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