June 2017 FDA Recall Morphine Sulfate by Tris Pharma Inc.
D-1126-2017 - Defective container
This Class II drug recall was voluntarily initiated by Tris Pharma Inc. on June 15, 2017 for the product Morphine Sulfate. The FDA reported the reason for recall as defective container. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1126-2017
Defective container: Oral solution leaking from container.
06-15-2017
09-06-2017
34,824 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Tris Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
U.S.A. Nationwide
11-08-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : 08215001A, Exp 6/30/2017; 08215002A, 08215004A, Exp 7/31/2017
