FDA Drug Class II — Moderate

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

Hazard

Defective container: Oral solution leaking from container.

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
Brand
Tris Pharma Inc.
UPC
Lot #: 08215001A, Exp 6/30/2017; 08215002A, 08215004A, Exp 7/31/2017

Units Affected

34,824 bottles