Why it was recalled
Presence of Particulate Matter: A single visible particulate was identified during a retain sample inspection.
Product description
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.
Lot numbers, UPCs & expiration codes
Lot #: 11-185-DJ*, 11-196-DJ*, Exp 1NOV2013; * may be followed by 01 or 02
Where it was sold
Nationwide and Puerto Rico
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-297-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 8, 2013
- FDA report date
- May 1, 2013
- Quantity
- 245,250 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-297-2013, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 64990
- Address
- 275 N Field Dr
- Code information
- Lot #: 11-185-DJ*, 11-196-DJ*, Exp 1NOV2013; * may be followed by 01 or 02
- Postal code
- 60045-2579
- Report date
- May 1, 2013
- Product type
- Drugs
- Recall number
- D-297-2013
- Classification
- Class II
- Recalling firm
- Hospira Inc.
- Product quantity
- 245,250 vials
- Termination date
- Nov 3, 2014
- Reason for recall
- Presence of Particulate Matter: A single visible particulate was identified during a retain sample inspection.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Apr 8, 2013
- Initial firm notification
- Letter
- Center classification date
- Apr 24, 2013