Why it was recalled
Presence of Particulate Matter: Glass defect located on the interior neck of the vial identified glass surface abrasions and visible embedded particulate matter which could result in the potential for small glass flakes or embedded metal particulate to become dislodged into the solution.
Product description
Propofol Injectible Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, packaged in 5 Units x 20 mL per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.
Lot numbers, UPCs & expiration codes
Lot #: 27-568-DJ*, Exp 03/15, Note * 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-1033-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 12, 2013
- FDA report date
- Jan 29, 2014
- Quantity
- 126,425 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-1033-2014, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 67322
- Address
- 275 N Field Dr
- Code information
- Lot #: 27-568-DJ*, Exp 03/15, Note * may be followed by 01
- Postal code
- 60045-2579
- Report date
- Jan 29, 2014
- Product type
- Drugs
- Recall number
- D-1033-2014
- Classification
- Class II
- Recalling firm
- Hospira Inc.
- Product quantity
- 126,425 vials
- Termination date
- Oct 16, 2014
- Reason for recall
- Presence of Particulate Matter: Glass defect located on the interior neck of the vial identified glass surface abrasions and visible embedded particulate matter which could result in the potential for small glass flakes or embedded metal particulate to become dislodged into the solution.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Propofol Injectible Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, packaged in 5 Units x 20 mL per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.
- Distribution pattern
- Nationwide
- Recall initiation date
- Dec 12, 2013
- Initial firm notification
- Letter
- Center classification date
- Jan 23, 2014