FDA Recall D-381-2014
Hospira Inc. · Lake Forest, IL
Class I — life-threatening Terminated 571 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
0.75% Bupivacaine HCl Injection, USP, 7.5 mg/mL, 30 mL, Single-dose, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1165-02
Reason for recall
Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.
Recall record
- Recall number
D-381-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide
- Recall initiated
- 2013-07-12
- Classified by FDA Center
- 2013-12-18
- FDA published
- 2013-12-25
- Terminated
- 2015-02-03
- Recalling firm
- Hospira Inc.
- Firm location
- Lake Forest, IL
Drug identification
- Brand name(s)
- BUPIVACAINE HYDROCHLORIDE
- Generic name(s)
- BUPIVACAINE HYDROCHLORIDE
- Manufacturer(s)
- Hospira, Inc.
- NDC(s)
0409-1159, 0409-1160, 0409-1162, 0409-1163, 0409-1165, 0409-9043, 0409-9046, 0409-9045, 0409-9042- Route(s)
- EPIDURAL, INFILTRATION, INTRACAUDAL, PERINEURAL