FDA recall D-0101-2024

Pfizer Inc. · Class I · drug

Product

1% Lidocaine HCl Injection, USP, 50mg/5mL(10mg/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 0409-4904-11

Reason for recall

Presence of Particulate Matter: identified as glass.

Distribution

Nationwide in the US and Puerto Rico. The products were not distributed to government accounts or foreign consignees.

Key facts

Status
Terminated
Initiation date
2023-10-02
Report date
2023-11-15
Termination date
2025-02-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0101-2024