FDA Drug recall D-0810-2016
Intermezzo (zolpidem tartrate) sublingual tablet 1.75 mg, CIV, 30 Ct Cartons, Rx Only
- FDA Drug
- Class III
- terminated
- Published 2016-04-13
On 2016-04-13 the FDA classified a Class III recall of Intermezzo (zolpidem tartrate) sublingual tablet 1.75 mg, CIV, 30 Ct Cartons, Rx Only by Purdue Pharma L P, citing failed Dissolution Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0810-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-03-31 |
| Published | 2016-04-13 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Purdue Pharma L P |
| Distribution | FL, LA, MI, MS, NC, NJ, OH, SC |
Product
Intermezzo (zolpidem tartrate) sublingual tablet 1.75 mg, CIV, 30 Ct Cartons, Rx Only. Dist by Purdue Pharma L.P., Stamford, CT 06901-3431. NDC: 59011-256-30.
Reason
Failed Dissolution Specifications
Identifiers
| code_info | Lot #: 3126431B, Expiry: 09/30/17 |
|---|
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-0810-2016%22
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