Recalls / Class II
Class IID-1033-2014
Product
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.
- Brand name
- Propofol
- Generic name
- Propofol
- Active ingredient
- Propofol
- Route
- Intravenous
- NDCs
- 0409-4699, 0409-6010
- FDA application
- ANDA077908
- Affected lot / code info
- Lot #: 27-568-DJ*, Exp 03/15, Note * may be followed by 01
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.
Recalling firm
- Firm
- Hospira Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 126,425 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-12-12
- FDA classified
- 2014-01-23
- Posted by FDA
- 2014-01-29
- Terminated
- 2014-10-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1033-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.