Recalls / Class I
Class ID-1216-2015
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
Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL Single Use Vials, Rx only. HOSPIRA, INC., LAKE FOREST, IL 60045 USA. NDC: 0409-1162-02.
- 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 #: 38-515-DK, Expiry: 1 FEB 2016.
Why it was recalled
Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles.
Recalling firm
- Firm
- Hospira Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 600 N Field Dr, N/A, Lake Forest, Illinois 60045-4835
Distribution
- Quantity
- 150,950 Vials
- Distribution pattern
- U.S. Nationwide including Guam.
Timeline
- Recall initiated
- 2015-04-23
- FDA classified
- 2015-07-08
- Posted by FDA
- 2015-07-15
- Terminated
- 2016-01-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1216-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.