FDA Drug recall D-1021-2018
Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701
- FDA Drug
- Class II
- terminated
- Published 2018-08-08
On 2018-08-08 the FDA classified a Class II recall of Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701 by Remedyrepack, 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-1021-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-07-17 |
| Published | 2018-08-08 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Remedyrepack |
| Distribution | FL |
Product
Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701
Reason
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Identifiers
| code_info | Lot # B0383153-122917; Exp. 12/18 |
|---|
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-1021-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.