Recalls / Class II
Class IID-1126-2017
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
- Brand name
- Morphine Sulfate
- Generic name
- Morphine Sulfate
- Active ingredient
- Morphine Sulfate
- Route
- Oral
- NDCs
- 27808-082, 27808-084
- FDA application
- ANDA203518
- Affected lot / code info
- Lot #: 08215001A, Exp 6/30/2017; 08215002A, 08215004A, Exp 7/31/2017
Why it was recalled
Defective container: Oral solution leaking from container.
Recalling firm
- Firm
- Tris Pharma Inc.
- Manufacturer
- Cranbury Pharmaceuticals, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2033 US Highway 130, N/A, Monmouth Junction, New Jersey 08852-3003
Distribution
- Quantity
- 34,824 bottles
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2017-06-15
- FDA classified
- 2017-08-29
- Posted by FDA
- 2017-09-06
- Terminated
- 2017-11-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1126-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.