Why it was recalled
Defective container: Oral solution leaking from container.
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
Lot numbers, UPCs & expiration codes
Lot #: 08215001A, Exp 6/30/2017; 08215002A, 08215004A, Exp 7/31/2017
Where it was sold
U.S.A. Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1126-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 15, 2017
- FDA report date
- Sep 6, 2017
- Quantity
- 34,824 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Tris Pharma Inc.
Original FDA data
Every field from FDA enforcement report D-1126-2017, exactly as published.
Show all FDA fields
- City
- Monmouth Junction
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 77798
- Address
- 2033 US Highway 130
- Code information
- Lot #: 08215001A, Exp 6/30/2017; 08215002A, 08215004A, Exp 7/31/2017
- Postal code
- 08852-3003
- Report date
- Sep 6, 2017
- Product type
- Drugs
- Recall number
- D-1126-2017
- Classification
- Class II
- Recalling firm
- Tris Pharma Inc.
- Product quantity
- 34,824 bottles
- Termination date
- Nov 8, 2017
- Reason for recall
- Defective container: Oral solution leaking from container.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- U.S.A. Nationwide
- Recall initiation date
- Jun 15, 2017
- Initial firm notification
- Letter
- Center classification date
- Aug 29, 2017