Recalls / Class II
Class IID-0381-2015
Product
Propofol Injectable Emulsion, 1%, 200 mg/20 mL, (10mg/mL), 20 mL, Single patient infusion vial, Contains Benzyl Alcohol, For I.V. Administration, 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 35-844-DJ, Exp 11/01/2015
Why it was recalled
Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron.
Recalling firm
- Firm
- Hospira Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 375 N Field Dr, N/A, Lake Forest, Illinois 60045-2513
Distribution
- Quantity
- 126,075 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-12-23
- FDA classified
- 2015-01-27
- Posted by FDA
- 2015-02-04
- Terminated
- 2015-07-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0381-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.