Recalls / Class I
Class ID-1278-2014
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
Lidocaine HCl Injection, USP, 2%, 20 mg per mL, packaged in 5-mL single-dose vials, 10 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL. 60045, NDC 0409-2066-05.
- Brand name
- Lidocaine Hydrochloride
- Generic name
- Lidocaine Hydrochloride
- Active ingredient
- Lidocaine Hydrochloride
- Route
- Epidural, Infiltration, Intracaudal, Perineural
- NDC
- 0409-2066
- FDA application
- ANDA040078
- Affected lot / code info
- Lot 32135DD; Exp 08/15
Why it was recalled
Presence of Particulate Matter- Confimed customer complaint of particulates embedded in glass container and in contact with product solution.
Recalling firm
- Firm
- Hospira Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 68,350 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-12-23
- FDA classified
- 2014-04-27
- Posted by FDA
- 2014-05-07
- Terminated
- 2014-10-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1278-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.