FDAClass IISeptember 6, 2017

Morphine Sulfate Oral Solution recall

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

Why was Morphine Sulfate Oral Solution recalled?

Defective container: Oral solution leaking from container.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 08215001A, Exp 6/30/2017; 08215002A, 08215004A, Exp 7/31/2017

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
Recalling firm
Tris Pharma Inc.
Quantity
34,824 bottles
Distribution
U.S.A. Nationwide
Recall date
September 6, 2017
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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