Recalls / Class II
Class IID-0898-2017
Product
Levophed norepinephrine bitartrate, injection, USP, 4 mg /4 mL (1 mg/mL),Rx only, Hospira, Inc. Lake Forest, IL --- 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
- 720503A, 720603A (Canada only)
Why it was recalled
GMP Deviation; A foreign stopper was observed during packaging of a lot of product.
Recalling firm
- Firm
- Hospira Inc., A Pfizer Company
- Manufacturer
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, N/A, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- (720503A): 43,200 vials, (720603A): 400 vials
- Distribution pattern
- Nationwide, Canada and Singapore
Timeline
- Recall initiated
- 2017-05-18
- FDA classified
- 2017-06-09
- Posted by FDA
- 2017-06-21
- Terminated
- 2019-05-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0898-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.