D-1126-2017 Class II Terminated
FDA drug recall D-1126-2017 was initiated by Tris Pharma Inc. on Jun 15, 2017 and is designated Class II. Reason for recall: Defective container: Oral solution leaking from container. The recall status is terminated (terminated Nov 8, 2017). Affected quantity: 34,824 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 6, 2017
- Initiation Date
- Jun 15, 2017
- Termination Date
- Nov 8, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 34,824 bottles
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
Reason for Recall
Defective container: Oral solution leaking from container.
Distribution Pattern
U.S.A. Nationwide
Code Information
Lot #: 08215001A, Exp 6/30/2017; 08215002A, 08215004A, Exp 7/31/2017
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1126-2017
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026