LIDOCAINE AND PRILOCAINE

Generic: LIDOCAINE AND PRILOCAINE

E. Fougera & Co. a division of Fougera PharmaceuticalsManufacturer
TOPICALRoute
LIDOCAINEActive Substance
2003-08-18Original Approval

LIDOCAINE AND PRILOCAINE is FDA application ANDA076453, sponsored by FOUGERA PHARMS. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2022-04-13
Lidocaine and Prilocaine Cream, 2.5%/2.5%, 5 gram tubes, Rx only, MFG: Sandoz Pharma, NDC 0168-0357-56

cGMP deviations: Temperature abuse

Top Reported Reactions

1
FATIGUE
156 reports
2
NAUSEA
120 reports
3
DIARRHOEA
107 reports
4
OFF LABEL USE
95 reports
5
VOMITING
79 reports
6
PYREXIA
70 reports
7
PRODUCT DOSE OMISSION ISSUE
68 reports
8
DEATH
67 reports
9
DYSPNOEA
65 reports
10
HEADACHE
65 reports