Drug recall
Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg, 30 pouches each containing 1 sublingual film…
FDA recall event 87372 · Class II · Alvogen, Inc
Key facts
| Event ID | 87372 |
|---|---|
| Recall numbers | D-0649-2021 |
| Recalling firm | Alvogen, Inc |
| Product type | Drugs |
| Products | Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg, 30 pouches each containing 1 sublingual film, Distributed by: Alvogen, Inc. Pine Brook, NJ 07058 USA, NDC 47781-355-03 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low) |
| Initiation date | Feb 26, 2021 |
| Report date | Jul 14, 2021 |
| Termination date | Feb 16, 2022 |
| City | Morristown |
| State | NJ |
| Country | United States |
| FEI number | 3008454186 |
At a glance
- 1–9 Products in this recall
- 1–9 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: