Recalls / Class I
Class ID-0391-2015
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
1% LIDOCAINE HCl Injection, USP, 10 mg/mL, 30 mL Single-dose, Preservative-Free glass vial (Twenty-five (25) units per box/fifty (50) units per case, NDC 0409-4279-02, 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# 40-316-DK, Exp 01APR2016
Why it was recalled
Presence of particulate matter: A returned customer sample was evaluated and found to have human hair attached to a pinched area of the stopper.
Recalling firm
- Firm
- Hospira Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 100,100 units
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-10-16
- FDA classified
- 2015-02-13
- Posted by FDA
- 2015-02-25
- Terminated
- 2015-12-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0391-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.