Why it was recalled
Presence of Particulate Matter: Visible particulate embedded in the glass vial was observed and confirmed in a sample bottle during retain sample inspection.
Product description
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), packaged in 5 Units x 20 mL Single patient infusion vials per carton, Rx only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-4699-30
Lot numbers, UPCs & expiration codes
Lot #: 24-461-DJ*, Exp 12/14; 26-543-DJ*, Exp 02/15; 27-555-DJ*, 27-559-DJ*, Exp 03/15; *lot number may be followed by 01
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-932-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 14, 2013
- FDA report date
- Sep 18, 2013
- Quantity
- 283,150 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-932-2013, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 66134
- Address
- 275 N Field Dr
- Code information
- Lot #: 24-461-DJ*, Exp 12/14; 26-543-DJ*, Exp 02/15; 27-555-DJ*, 27-559-DJ*, Exp 03/15; *lot number may be followed by 01
- Postal code
- 60045-2579
- Report date
- Sep 18, 2013
- Product type
- Drugs
- Recall number
- D-932-2013
- Classification
- Class II
- Recalling firm
- Hospira Inc.
- Product quantity
- 283,150 vials
- Termination date
- Sep 18, 2014
- Reason for recall
- Presence of Particulate Matter: Visible particulate embedded in the glass vial was observed and confirmed in a sample bottle during retain sample inspection.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), packaged in 5 Units x 20 mL Single patient infusion vials per carton, Rx only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-4699-30
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 14, 2013
- Initial firm notification
- Letter
- Center classification date
- Sep 9, 2013