Recalls / Class II
Class IID-099-2013
Product
Lidocaine HCl Injection, USP, 1% (10 mg/mL), 30 mL Single-dose Teartop Vial, packaged in 25-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045; 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 #: 14-277-DK*, Exp 02/01/14; * may be followed by 01
Why it was recalled
Presence of Particulate Matter: Report of a vial containing visible particulate matter embedded in the glass wall which has the potential to dislodge resulting in the presence of particulate matter in the product.
Recalling firm
- Firm
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 600 N Field Dr Bldg J45, Lake Forest, Illinois 60045
Distribution
- Quantity
- 120,350 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-10-04
- FDA classified
- 2012-12-20
- Posted by FDA
- 2012-12-26
- Terminated
- 2014-05-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-099-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.