Recalls / Class II
Class IID-66201-001
Product
5% Lidocaine HCl and 7.5% Dextrose Injection, USP, 2 mL Single Dose Ampuls, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4712-01
- Affected lot / code info
- Lot 23-227-DK
Why it was recalled
Presence of Particulate Matter; report of visible particulates in the glass ampule
Recalling firm
- Firm
- Hospira Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 86,400 ampuls
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-08-29
- FDA classified
- 2013-10-02
- Posted by FDA
- 2013-10-09
- Terminated
- 2014-11-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-66201-001. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.