FDA Drug recall D-1122-2019
Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufactured for: AvKARE, Inc
- FDA Drug
- Class III
- terminated
- Published 2019-04-17
On 2019-04-17 the FDA classified a Class III recall of Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufactured for: AvKARE, Inc by Avkare, citing failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer).
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1122-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-04-03 |
| Published | 2019-04-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Avkare |
| Distribution | AZ, CO |
Product
Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478 --- NDC 42291-795-30
Reason
Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer)
Identifiers
| code_info | Lots: 201916 Exp. 08/2019; 20092 Exp. 08/2019 |
|---|
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-1122-2019%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.