Drug recall D-1126-2017

Class II Terminated reported Sep 6, 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.

Lots and codes

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

Recall details

Recalling firm
Tris Pharma Inc., Monmouth Junction, NJ
Quantity
34,824 bottles
Distribution
U.S.A. Nationwide
Type
Voluntary: Firm initiated
Recall initiated
June 15, 2017
Terminated
November 8, 2017

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