FDA recall D-1126-2017

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 for recall

Defective container: Oral solution leaking from container.

Distribution

U.S.A. Nationwide

Key facts

Status

Terminated

Initiation date

2017-06-15

Report date

2017-09-06

Termination date

2017-11-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Monmouth Junction, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1126-2017