Recalls / Class I
Class ID-0102-2024
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
2% Lidocaine HCl Injection, USP, 100mg/5mL(20mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Distributed by Hospira Inc., Lake Forest, IL 60045, NDC 0409-4903-11
- Brand name
- Lidocaine Hydrochloride
- Generic name
- Lidocaine Hydrochloride
- Active ingredient
- Lidocaine Hydrochloride
- Route
- Intravenous
- NDCs
- 0409-1323, 0409-4903, 0409-4904, 0409-9137
- FDA application
- ANDA040302
- Affected lot / code info
- Lot#: GH6567, Exp. 7/1/2024
Why it was recalled
Presence of Particulate Matter: identified as glass.
Recalling firm
- Firm
- Pfizer Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 East 42nd Street, New York, New York 10017-5703
Distribution
- Quantity
- 3,200 vials
- Distribution pattern
- Nationwide in the US and Puerto Rico. The products were not distributed to government accounts or foreign consignees.
Timeline
- Recall initiated
- 2023-10-02
- FDA classified
- 2023-11-09
- Posted by FDA
- 2023-11-15
- Terminated
- 2025-02-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0102-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.