Drug 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
D-1126-2017
Product summary
- Firm
- Tris Pharma Inc.
- Event
- Event 77798
- Status
- Terminated
- Classification
- Class II
- Quantity
- 34,824 bottles
- Official record key
drug-enforcement:D-1126-2017
Official wording
Reason: Defective container: Oral solution leaking from container.
Code information: Lot #: 08215001A, Exp 6/30/2017; 08215002A, 08215004A, Exp 7/31/2017
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Unknown
Defective container: Oral solution leaking from container.