Why it was recalled
Lack of Assurance of Sterility: Confirmed customer report of leakage of vial contents due to the breaking of the vial neck.
Product description
Morphine Sulfate Injection, USP, (25mg/mL), 250 mg, 10mL Fill, Single dosage Flip top Vial, (C-II), (NDC 0409-1135-02), Rx Only, Manfactured for Hospira, Inc., Lake Forest, IL 60045 USA.
Lot numbers, UPCs & expiration codes
Lot #17368EV Exp 08/13
Where it was sold
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-023-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 16, 2013
- FDA report date
- Dec 11, 2013
- Quantity
- 29,700 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira, Inc.
Original FDA data
Every field from FDA enforcement report D-023-2014, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 66435
- Address
- 600 N Field Dr Bldg J45
- Code information
- Lot #17368EV Exp 08/13
- Postal code
- 60045
- Report date
- Dec 11, 2013
- Product type
- Drugs
- Recall number
- D-023-2014
- Classification
- Class II
- Recalling firm
- Hospira, Inc.
- Product quantity
- 29,700 vials
- Termination date
- Oct 28, 2014
- Reason for recall
- Lack of Assurance of Sterility: Confirmed customer report of leakage of vial contents due to the breaking of the vial neck.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Morphine Sulfate Injection, USP, (25mg/mL), 250 mg, 10mL Fill, Single dosage Flip top Vial, (C-II), (NDC 0409-1135-02), Rx Only, Manfactured for Hospira, Inc., Lake Forest, IL 60045 USA.
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 16, 2013
- Initial firm notification
- Letter
- Center classification date
- Dec 2, 2013