Recalls / Class I
Class ID-0382-2015
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, Preservative-Free, 10 mg/mL, 30 mL Single-dose vials, packaged in 25-count cartons, 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 number: 31-427-DK, Exp 01JUL2015.
Why it was recalled
Presence of Particulate Matter: Confirmed customer complaint that orange and black particulates, identified as iron oxide, were found embedded within the glass vial and floating in solution.
Recalling firm
- Firm
- Hospira Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 375 N Field Dr, N/A, Lake Forest, Illinois 60045-2513
Distribution
- Quantity
- 120,900 vials
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2014-04-18
- FDA classified
- 2015-01-30
- Posted by FDA
- 2015-02-11
- Terminated
- 2017-11-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0382-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.