Recalls / Class II
Class IID-1815-2015
Product
1% Lidocaine HCl Injection, USP, 10 mg/mL, 30 mL Vial, Single-dose Preservative Free, Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-4279-02
- 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 #: 44-359-DK, Exp 08/01/2016
Why it was recalled
Presence of Particulate Matter: particulate matter identified as iron oxide, was found embedded in the neck of glass vials.
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
- 100,200 Vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-08-25
- FDA classified
- 2015-09-18
- Posted by FDA
- 2015-09-30
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-1815-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.