Reported Sep 6, 2017 · Terminated

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

Tris Pharma Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Tris Pharma Inc. · 2033 US Highway 130 · Monmouth Junction, NJ · 08852-3003

Is this the product you have?

  • 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 byTris Pharma, Inc. Monmouth Junction, NJ 08852, NDC 27808-082-01
Lot codes and dates
    • Lot #: 08215001A
    • Exp 6/30/2017
    • 08215002A
    • 08215004A
    • Exp 7/31/2017
Amount recalled
34,824 bottles

Where it was sold

  • Nationwide

Why it was recalled

Defective container: Oral solution leaking from container.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Nov 8, 2017 · Data as of Sep 19, 5:51 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.