FDA Drug recall D-0984-2017
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg 30 tablets per Bottle, Rx only, Distributed By: Teva Pharmaceuticals USA, Inc., Nor…
- FDA Drug
- Class III
- terminated
- Published 2017-07-26
On 2017-07-26 the FDA classified a Class III recall of Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg 30 tablets per Bottle, Rx only, Distributed By: Teva Pharmaceuticals USA, Inc., Nor… by Teva Pharmaceuticals Usa, citing failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0984-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-06-29 |
| Published | 2017-07-26 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | US |
Product
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg 30 tablets per Bottle, Rx only, Distributed By: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5721-56
Reason
Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.
Identifiers
| code_info | Lot #: 30227649A ,30227650A, 30227651A, 30227652A, 30227653A, 30227654A, 30227655A, 30227832A, 30227833A, 30227834A, 3…Lot #: 30227649A ,30227650A, 30227651A, 30227652A, 30227653A, 30227654A, 30227655A, 30227832A, 30227833A, 30227834A, 30227835A, EXP 06/2017; 30228561A, 30228562A, 30228563A, 30228564A, 30228565A, 30228566A, 30228567A, 30228568A, 30228569A, 30228570A, EXP 9/2017; 3000124, 3000125, EXP 7/2018; 3000392, 3000393, 3000394, EXP 9/2018; 3000872, 3000874, EXP 10/2018; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0984-2017%22
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