Recalls / Class I
Class ID-1358-2014
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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.
- Brand name
- Marcaine
- Generic name
- Bupivacaine Hydrochloride
- Active ingredient
- Bupivacaine Hydrochloride
- Route
- Perineural
- NDCs
- 0409-0525, 0409-1559, 0409-1560, 0409-1582, 0409-1587, 0409-1610, 0409-1746, 0409-1749, 0409-1752, 0409-1755 +7 more
- FDA application
- NDA016964
- Affected lot / code info
- Lot #: 34-440-DD, Exp 10/15
Why it was recalled
Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.
Recalling firm
- Firm
- Hospira Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 85,680 vials
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2014-04-21
- FDA classified
- 2014-06-05
- Posted by FDA
- 2014-06-11
- Terminated
- 2017-03-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1358-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.