Morphine Sulfate Solution
FDA Recall NDC 27808-082
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Morphine Sulfate (NDC 27808-082). A significant event, classified as Class II, was initiated on Jun 15, 2017 by Cranbury Pharmaceuticals, Llc. The reported reason for this action was: "Defective container: Oral solution leaking from container."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Defective container: Oral solution leaking from container.
Jun 15, 2017
Sep 06, 2017
34,824 bottles
Recall Profile & Regulatory Data
Event ID
77798
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Tris Pharma Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A. Nationwide
Termination Date
Nov 08, 2017
Product Description
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
Affected Packages Involved in this Recall
27808-084-01Product
27808-084-02Product
27808-082-01Product
27808-082-02Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
