FDA Recall D-0020-2015
Hospira Inc. · Lake Forest, IL
Class I — life-threatening Terminated 962 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Lidocaine HCl Injection, USP, 2%, 20 mg per mL, Preservative-Free, 5 mL Single-Dose Vial, Rx only, For Infiltration and Nerve Block including Epidural and Caudal, Manufactured by: Hospira, Inc., Lake Forest, IL, 60045, NDC 0409-2066-05
Reason for recall
Presence of Particulate Matter: The product was discolored and contained visible particulates (iron oxide) in the solution and embedded in the glass vial.
Recall record
- Recall number
D-0020-2015- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide
- Recall initiated
- 2014-07-29
- Classified by FDA Center
- 2014-10-10
- FDA published
- 2014-10-22
- Terminated
- 2017-03-17
- 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)
0409-2066- Route(s)
- EPIDURAL, INFILTRATION, INTRACAUDAL, PERINEURAL