FDA Recall D-0391-2015
Hospira Inc. · Lake Forest, IL
Class I — life-threatening Terminated 439 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
1% LIDOCAINE HCl Injection, USP, 10 mg/mL, 30 mL Single-dose, Preservative-Free glass vial (Twenty-five (25) units per box/fifty (50) units per case, NDC 0409-4279-02, Hospira, Inc., Lake Forest, IL 60045
Reason for recall
Presence of particulate matter: A returned customer sample was evaluated and found to have human hair attached to a pinched area of the stopper.
Recall record
- Recall number
D-0391-2015- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide
- Recall initiated
- 2014-10-16
- Classified by FDA Center
- 2015-02-13
- FDA published
- 2015-02-25
- Terminated
- 2015-12-29
- Recalling firm
- Hospira Inc.
- Firm location
- Lake Forest, IL
Drug identification
- Brand name(s)
- LIDOCAINE HYDROCHLORIDE
- Generic name(s)
- LIDOCAINE HYDROCHLORIDE
- Manufacturer(s)
- Hospira, Inc.
- NDC(s)
0409-4275, 0409-4713, 0409-4278, 0409-4279, 0409-4776, 0409-4282, 0409-4277, 0409-4276- Route(s)
- INFILTRATION, PERINEURAL