Why it was recalled
Presence of Particulate Matter; single visible particulate was identified during a retain sample inspection identified as stainless steel
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, NDC 0409-4699-24; Propofol Injectable Emulsion, 500 mg/50 mL, 50 mL, Single patient infusion vial, RX only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-33
Lot numbers, UPCs & expiration codes
Lot 07-950-DJ Exp. Date 1JUL2013, 10-101-DJ Exp. Date 1OCT2013, and 10-102-DJ Exp. Date 1OCT2013
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-887-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 25, 2013
- FDA report date
- Aug 21, 2013
- Quantity
- 94,110 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-887-2013, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 65616
- Address
- 275 N Field Dr
- Code information
- Lot 07-950-DJ Exp. Date 1JUL2013, 10-101-DJ Exp. Date 1OCT2013, and 10-102-DJ Exp. Date 1OCT2013
- Postal code
- 60045-2579
- Report date
- Aug 21, 2013
- Product type
- Drugs
- Recall number
- D-887-2013
- Classification
- Class II
- Recalling firm
- Hospira Inc.
- Product quantity
- 94,110 vials
- Termination date
- Sep 18, 2014
- Reason for recall
- Presence of Particulate Matter; single visible particulate was identified during a retain sample inspection identified as stainless steel
- 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, NDC 0409-4699-24; Propofol Injectable Emulsion, 500 mg/50 mL, 50 mL, Single patient infusion vial, RX only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-33
- Distribution pattern
- Nationwide
- Recall initiation date
- May 25, 2013
- Initial firm notification
- Letter
- Center classification date
- Aug 13, 2013