Tris Pharma Inc. recalls Morphine Sulfate Oral Solution, 100 mg/ 5 mL (20 mg/mL), packaged in a 1 oz. bottle containing 30 mL with an oral syrin…

Recall date

June 15, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1126-2017

FDA classification

Class II

Brand / firm

Tris Pharma Inc.

Sold / distributed

U.S.A. Nationwide

Why it was recalled

Defective container: Oral solution leaking from container.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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