Recalls / Class I
Class ID-1234-2014
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
1% Lidocaine HCl Injection, USP, 10 mg/mL, NDC 0409-4276-01, Hospira, Inc., Lake Forest, IL 60045.
- Brand name
- Lidocaine Hydrochloride
- Generic name
- Lidocaine Hydrochloride
- Active ingredient
- Lidocaine Hydrochloride
- Route
- Infiltration, Perineural
- NDCs
- 0409-4275, 0409-4713, 0409-4278, 0409-4279, 0409-4776, 0409-4282, 0409-4277, 0409-4276
- FDA application
- ANDA088325
- Affected lot / code info
- Lot #25090DK; Exp 01/15
Why it was recalled
Presence of Particulate Matter: Oxidized stainless steel found in vial of 1% Lidocaine Hydrochloride Injection, USP.
Recalling firm
- Firm
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 600 N Field Dr Bldg J45, N/A, Lake Forest, Illinois 60045
Distribution
- Quantity
- 374,500 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-09-16
- FDA classified
- 2014-04-14
- Posted by FDA
- 2014-04-23
- Terminated
- 2014-11-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1234-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.