FDA recall D-0636-2024

Fagron Compounding Services · Class II · drug

Product

Lidocaine HCl Injection, 2% (20mg per mL) (100 mg per 5 mL) per syringe, Rx only, Fagron Sterile Services, 8710 E. 34th St, N. Wichita, KS 57226.

Reason for recall

Lack of Assurance of Sterility

Distribution

Nationwide in the USA

Key facts

Status
Ongoing
Initiation date
2024-08-15
Report date
2024-08-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Wichita, KS, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0636-2024