Why it was recalled
Presence of Particulate Matter: A single visible particulate was observed and confirmed in a sample bottle during retain inspection.
Product description
Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 ml Single patient infusion vial, Rx only, Hospira, Inc. Lake Forest, IL 60045 USA, NDC 0409-4699-24
Lot numbers, UPCs & expiration codes
07-893-DJ, exp. 7/2013, 10-123-DJ, 10-125-DJ, exp. 10/2013
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-1672-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 3, 2012
- FDA report date
- Sep 5, 2012
- Quantity
- 56,420 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-1672-2012, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 62999
- Address
- 375 N Field Dr
- Code information
- 07-893-DJ, exp. 7/2013, 10-123-DJ, 10-125-DJ, exp. 10/2013
- Postal code
- 60045-2513
- Report date
- Sep 5, 2012
- Product type
- Drugs
- Recall number
- D-1672-2012
- Classification
- Class II
- Recalling firm
- Hospira Inc.
- Product quantity
- 56,420 vials
- Termination date
- May 6, 2014
- Reason for recall
- Presence of Particulate Matter: A single visible particulate was observed and confirmed in a sample bottle during retain inspection.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 ml Single patient infusion vial, Rx only, Hospira, Inc. Lake Forest, IL 60045 USA, NDC 0409-4699-24
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 3, 2012
- Initial firm notification
- Letter
- Center classification date
- Aug 30, 2012