Recalls / Class II
Class IID-1168-2017
Product
Levophed (norepinephrine bitartrate) injection, USP, 4 mg/4 mL (1mg/mL), 4mL Fill in 5 mL Single dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3375-04
- Brand name
- Levophed
- Generic name
- Norepinephrine Bitartrate
- Active ingredient
- Norepinephrine Bitartrate
- Route
- Intravenous
- NDCs
- 0409-3375, 0409-1443
- FDA application
- NDA007513
- Affected lot / code info
- Lot #: 753003A, Exp 9/18; 762153A, 760803A, 761053A , Exp 10/18
Why it was recalled
Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
Recalling firm
- Firm
- Pfizer Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 E 42nd St, N/A, New York, New York 10017-5703
Distribution
- Quantity
- 98,050 vials
- Distribution pattern
- United States Nationwide (including Puerto Rico) and Singapore
Timeline
- Recall initiated
- 2017-08-22
- FDA classified
- 2017-09-15
- Posted by FDA
- 2017-09-27
- Terminated
- 2023-02-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1168-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.