Recall: D-1126-2017

Class II - Potentially Harmful

Class IIClassification

2017-06-15Initiated

TerminatedStatus

Tris Pharma Inc.Firm

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.

Distribution

U.S.A. Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.