FDA Recall D-1358-2014
Hospira Inc. · Lake Forest, IL
Class I — life-threatening Terminated 1060 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%, Preservative-Free, 10 mL (25 mg) Single-dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USP, NDC 0409-1559-10.
Reason for recall
Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.
Recall record
- Recall number
D-1358-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide.
- Recall initiated
- 2014-04-21
- Classified by FDA Center
- 2014-06-05
- FDA published
- 2014-06-11
- Terminated
- 2017-03-16
- 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