Recalls / Class I
Class ID-0020-2015
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
Lidocaine HCl Injection, USP, 2%, 20 mg per mL, Preservative-Free, 5 mL Single-Dose Vial, Rx only, For Infiltration and Nerve Block including Epidural and Caudal, Manufactured by: 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 Number: 25-550-DD, Exp: 1JAN2015
Why it was recalled
Presence of Particulate Matter: The product was discolored and contained visible particulates (iron oxide) in the solution and embedded in the glass vial.
Recalling firm
- Firm
- Hospira Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, N/A, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 109,110 Vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-07-29
- FDA classified
- 2014-10-10
- Posted by FDA
- 2014-10-22
- Terminated
- 2017-03-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0020-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.