Recalls / Class II
Class IID-1588-2014
Product
Bupivacaine HCl Inj., USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative-Free, For Nerve Block, Caudal, and Epidural Anesthesia, Not for Spinal Anesthesia, 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 37-268-DK; Exp: 1JAN2016
Why it was recalled
Presence of Particulate Matter: A confirmed customer complaint reported the presence of a brown, rust-colored particle embedded at the bottom of the glass vial.
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
- 75,000 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-09-04
- FDA classified
- 2014-09-17
- Posted by FDA
- 2014-09-24
- Terminated
- 2015-07-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1588-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.