Recalls / Class II
Class IID-395-2014
Product
0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 50 mL, Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045. NDC #0409-9046-01.
- Brand name
- Bupivacaine Hydrochloride
- Generic name
- Bupivacaine Hydrochloride
- Active ingredient
- Bupivacaine Hydrochloride
- Route
- Epidural, Infiltration, Intracaudal, Perineural
- NDCs
- 0409-1159, 0409-1160, 0409-1162, 0409-1163, 0409-1165, 0409-9043, 0409-9046, 0409-9045, 0409-9042
- FDA application
- ANDA070583
- Affected lot / code info
- Lot #32-484-EV, 32-485-EV Exp: 2/2015.
Why it was recalled
Lack of assurance of sterility; equipment failure led to potential breach in asceptic process.
Recalling firm
- Firm
- Hospira Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 375 N Field Dr, Lake Forest, Illinois 60045-2513
Distribution
- Quantity
- 65109 vials
- Distribution pattern
- US Nationwide.
Timeline
- Recall initiated
- 2013-10-11
- FDA classified
- 2014-01-02
- Posted by FDA
- 2014-01-08
- Terminated
- 2014-11-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-395-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.