FDA recall D-0421-2018

Webrx dba RxPalace.com · Class III · drug

Product

BonaDur For Men (lidocaine) spray, 10 mg per spray, Net Contents .25 fl. oz. (7.4 mL) spray bottles, Manufactured by WebRx Pharmacy Palace, Sarasota, FL 34232; NDC 70582-999-74

Reason for recall

CGMP Deviations: not manufactured according to current good manufacturing practices.

Distribution

NY

Key facts

Status
Terminated
Initiation date
2018-02-07
Report date
2018-02-21
Termination date
2020-05-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Sarasota, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0421-2018