Recalls / Class II
Class IID-887-2013
Product
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
- Brand name
- Propofol
- Generic name
- Propofol
- Active ingredient
- Propofol
- Route
- Intravenous
- NDCs
- 0409-4699, 0409-6010
- FDA application
- ANDA077908
- Affected lot / code info
- Lot 07-950-DJ Exp. Date 1JUL2013, 10-101-DJ Exp. Date 1OCT2013, and 10-102-DJ Exp. Date 1OCT2013
Why it was recalled
Presence of Particulate Matter; single visible particulate was identified during a retain sample inspection identified as stainless steel
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
- 94,110 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-05-25
- FDA classified
- 2013-08-13
- Posted by FDA
- 2013-08-21
- Terminated
- 2014-09-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-887-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.