FDA Recall D-1161-2014
Hospira Inc. · Lake Forest, IL
Class I — life-threatening Terminated 791 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Marcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-preservative free, packaged in 10-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1559-30.
Reason for recall
Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in the solution causing the product to be discolored.
Recall record
- Recall number
D-1161-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide
- Recall initiated
- 2013-10-18
- Classified by FDA Center
- 2014-03-14
- FDA published
- 2014-03-26
- Terminated
- 2015-12-18
- Recalling firm
- Hospira Inc.
- Firm location
- Lake Forest, IL
Drug identification
- Brand name(s)
- MARCAINE
- Generic name(s)
- BUPIVACAINE HYDROCHLORIDE
- Manufacturer(s)
- Hospira, Inc.
- NDC(s)
0409-0525, 0409-1559, 0409-1560, 0409-1582, 0409-1587, 0409-1610, 0409-1746, 0409-1749, 0409-1752, 0409-1755, 0409-2510, 0409-7535, 0409-1250, 0409-5010, 0409-1530, 0409-7510, 0409-2253- Route(s)
- PERINEURAL