FDA Drug recall D-1126-2017
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, Manufac…
- FDA Drug
- Class II
- terminated
- Published 2017-09-06
On 2017-09-06 the FDA classified a Class II recall of 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, Manufac… by Tris Pharma, citing defective container: Oral solution leaking from container.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1126-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-06-15 |
| Published | 2017-09-06 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Tris Pharma |
| Distribution | US |
Product
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 27808-082-01
Reason
Defective container: Oral solution leaking from container.
Identifiers
| ndc | 27808-084-01 |
|---|---|
| ndc | 27808-084-02 |
| ndc | 27808-082-01 |
| ndc | 27808-082-02 |
| code_info | Lot #: 08215001A, Exp 6/30/2017; 08215002A, 08215004A, Exp 7/31/2017 |
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-1126-2017%22
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