Drug recall
Intermezzo (zolpidem tartrate), sublingual tablet 3.5 mg, 1 tablet per pouch, 30 pouches per carton, Rx only…
FDA recall event 71732 · Class III · Purdue Pharma L.P.
Key facts
| Event ID | 71732 |
|---|---|
| Recall numbers | D-1278-2015 |
| Recalling firm | Purdue Pharma L.P. |
| Product type | Drugs |
| Products | Intermezzo (zolpidem tartrate), sublingual tablet 3.5 mg, 1 tablet per pouch, 30 pouches per carton, Rx only, Distributed by Purdue Pharma L.P. Stamford, CT 06901-3431, NDC 59011-265-30 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed dissolution specifications |
| Initiation date | Jul 13, 2015 |
| Report date | Jul 29, 2015 |
| Termination date | May 15, 2017 |
| City | Stamford |
| State | CT |
| Country | United States |
| FEI number | 3004365793 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: