FDA Drug recall D-0966-2018
Unit Dose Valsartan Tablets, USP, 80 mg
- FDA Drug
- Class II
- terminated
- Published 2018-08-01
On 2018-08-01 the FDA classified a Class II recall of Unit Dose Valsartan Tablets, USP, 80 mg by Major Pharmaceuticals, 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-0966-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-07-18 |
| Published | 2018-08-01 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Major Pharmaceuticals |
| Distribution | US |
Product
Unit Dose Valsartan Tablets, USP, 80 mg. Rx only, Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61.
Reason
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Identifiers
| code_info | Major Label Unit Dose 10 x 10 Cartons 80 mg Item # 302086. Lot# T-01270 (Expiry: 7/18). Lot# T-01466 (Expiry: 7/18). Lo…Major Label Unit Dose 10 x 10 Cartons 80 mg Item # 302086. Lot# T-01270 (Expiry: 7/18). Lot# T-01466 (Expiry: 7/18). Lot# T-01500 (Expiry:2/19). Lot# T-01596 (Expiry: 2/19). Lot# T-01625 (Expiry: 2/19). Lot# T-01712 (Expiry: 2/19). Lot# T-01795 (5/19). Lot# T-01807 (Expiry: 5/19). |
|---|
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-0966-2018%22
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