Why it was recalled
Presence of Particulate Matter: A single visible particulate was observed and confirmed in sample bottles of the recalled lots during retain inspection.
Product description
Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusion vial, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 50 mL Single patient infusion vial, 500 mg/50 mL (10 mg/mL), NDC 0409-4699-33; c) 100 mL Single patient infusion vial, 1 g/100 mL (10 mg/mL), NDC 0409-4699-24; Rx only, Hospira, Inc., Lake Forest, IL 60045 USA
Lot numbers, UPCs & expiration codes
Lot No: a) 93-857-DJ, 93-896-DJ, Exp 1SEP2012; 04-515-DJ, Exp 1APR2013; 06-802-DJ, Exp 1JUN2013; b) 01-175-DJ, Exp 1JAN2013; 04-565-DJ, Exp 1APR2013; c) 03-388-DJ, Exp 1MAR2013; The lot number may be followed by 01 or 02
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-1685-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 29, 2012
- FDA report date
- Oct 3, 2012
- Quantity
- 148,630 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-1685-2012, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 63198
- Address
- 275 N Field Dr
- Code information
- Lot No: a) 93-857-DJ, 93-896-DJ, Exp 1SEP2012; 04-515-DJ, Exp 1APR2013; 06-802-DJ, Exp 1JUN2013; b) 01-175-DJ, Exp 1JAN2013; 04-565-DJ, Exp 1APR2013; c) 03-388-DJ, Exp 1MAR2013; The lot number may be followed by 01 or 02
- Postal code
- 60045-2579
- Report date
- Oct 3, 2012
- Product type
- Drugs
- Recall number
- D-1685-2012
- Classification
- Class II
- Recalling firm
- Hospira Inc.
- Product quantity
- 148,630 vials
- Termination date
- Aug 8, 2013
- Reason for recall
- Presence of Particulate Matter: A single visible particulate was observed and confirmed in sample bottles of the recalled lots during retain inspection.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusion vial, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 50 mL Single patient infusion vial, 500 mg/50 mL (10 mg/mL), NDC 0409-4699-33; c) 100 mL Single patient infusion vial, 1 g/100 mL (10 mg/mL), NDC 0409-4699-24; Rx only, Hospira, Inc., Lake Forest, IL 60045 USA
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 29, 2012
- Initial firm notification
- Letter
- Center classification date
- Sep 21, 2012