Why it was recalled
Presence of Particulate Matter: A single visible particulate was observed in a retention sample bottles identified as stainless steel
Product description
Propofol Injectable Emulsion, 1%, (10mg/mL), packaged in a) 200 mg/20 mL, 5 Units x 20 mL Single patient infusion vials per carton (NDC 0409-4699-30); b) 1 g/100 mL, 10 Units x 100 mL Single patient infusion vials per carton (NDC 0409-4699-24); Rx only, Hospira, Inc., Lake Forest, IL 60045, USA.
Lot numbers, UPCs & expiration codes
Lot #: a) 03440DJ*, Exp 1MAR2013; b) 07947DJ, Exp 1JUL2013; 10134DJ, Exp 1OCT2013; Note: * the lot 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-1382-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 11, 2012
- FDA report date
- Jun 20, 2012
- Quantity
- a) 36,125 vials; b) 31,280 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira, Inc.
Original FDA data
Every field from FDA enforcement report D-1382-2012, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 62009
- Address
- 600 N Field Dr Bldg J45
- Code information
- Lot #: a) 03440DJ*, Exp 1MAR2013; b) 07947DJ, Exp 1JUL2013; 10134DJ, Exp 1OCT2013; Note: * the lot may be followed by 01.
- Postal code
- 60045
- Report date
- Jun 20, 2012
- Product type
- Drugs
- Recall number
- D-1382-2012
- Classification
- Class II
- Recalling firm
- Hospira, Inc.
- Product quantity
- a) 36,125 vials; b) 31,280 vials
- Termination date
- Jun 27, 2013
- Reason for recall
- Presence of Particulate Matter: A single visible particulate was observed in a retention sample bottles identified as stainless steel
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Propofol Injectable Emulsion, 1%, (10mg/mL), packaged in a) 200 mg/20 mL, 5 Units x 20 mL Single patient infusion vials per carton (NDC 0409-4699-30); b) 1 g/100 mL, 10 Units x 100 mL Single patient infusion vials per carton (NDC 0409-4699-24); Rx only, Hospira, Inc., Lake Forest, IL 60045, USA.
- Distribution pattern
- Nationwide.
- Recall initiation date
- Apr 11, 2012
- Initial firm notification
- Letter
- Center classification date
- Jun 14, 2012