Drug recall
Morphine Sulfate Oral Solution, 100 mg/ 5 mL (20 mg/mL), packaged in a 1 oz. bottle containing 30 mL with an…
FDA recall event 77798 · Class II · Tris Pharma Inc.
Key facts
| Event ID | 77798 |
|---|---|
| Recall numbers | D-1126-2017 |
| Recalling firm | Tris Pharma Inc. |
| Product type | Drugs |
| Products | Morphine Sulfate Oral Solution, 100 mg/ 5 mL (20 mg/mL), packaged in a 1 oz. bottle containing 30 mL with an oral syringe, Rx Only, Manufactured by: Tris Pharma, Inc. Monmouth Junction, NJ 08852, NDC… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Defective container: Oral solution leaking from container. |
| Initiation date | Jun 15, 2017 |
| Report date | Sep 6, 2017 |
| Termination date | Nov 8, 2017 |
| City | Monmouth Junction |
| State | NJ |
| Country | United States |
| FEI number | 3004712471 |
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: