TAVABOROLE

Generic: TAVABOROLE

Alembic Pharmaceuticals Inc.Manufacturer
TOPICALRoute
TAVABOROLEActive Substance
2020-10-21Original Approval

TAVABOROLE is FDA application ANDA212188, sponsored by ALEMBIC. 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 II2025-10-06
Tavaborole Topical solution 5%, 10 mL bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Changodar, Ahmedabad, I

Discoloration

Class II2025-08-12
Tavaborole Topical Solution 5%, 10 mL per glass bottle, Rx Only, For Topical Use Only, Manufactured by: Zydus Lifescienc

Discoloration

Top Reported Reactions

1
DRUG INEFFECTIVE
11 reports
2
INJECTION SITE PAIN
4 reports
3
OFF LABEL USE
4 reports
4
PRODUCT DOSE OMISSION IN ERROR
4 reports
5
COUGH
3 reports
6
PRODUCT PACKAGING QUANTITY ISSUE
3 reports
7
PRURITUS
3 reports
8
RASH
3 reports
9
SKIN IRRITATION
3 reports
10
ACCIDENTAL EXPOSURE TO PRODUCT
2 reports