Recalls / Class I
Class ID-381-2014
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
0.75% Bupivacaine HCl Injection, USP, 7.5 mg/mL, 30 mL, Single-dose, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1165-02
- Brand name
- Bupivacaine Hydrochloride
- Generic name
- Bupivacaine Hydrochloride
- Active ingredient
- Bupivacaine Hydrochloride
- Route
- Epidural, Infiltration, Intracaudal, Perineural
- NDCs
- 0409-1159, 0409-1160, 0409-1162, 0409-1163, 0409-1165, 0409-9043, 0409-9046, 0409-9045, 0409-9042
- FDA application
- ANDA070583
- Affected lot / code info
- Lot # 23-338-DK, Exp. 11/14
Why it was recalled
Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.
Recalling firm
- Firm
- Hospira Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, N/A, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 119,600 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-07-12
- FDA classified
- 2013-12-18
- Posted by FDA
- 2013-12-25
- Terminated
- 2015-02-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-381-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.