FDA Drug recall 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, P…
- FDA Drug
- Class II
- terminated
- Published 2018-08-08
On 2018-08-08 the FDA classified a Class II recall of 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, P… by Bryant Ranch Prepack, citing CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1027-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-07-27 |
| Published | 2018-08-08 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Bryant Ranch Prepack |
| Distribution | FL, HI, IN |
Product
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
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Identifiers
| code_info | Lot # 111158; Exp. 02/19 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1027-2018%22
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