FDA recall D-0616-2018

Product

Fabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834; NDC 51862-295-10.

Reason for recall

Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2018-03-21

Report date

2018-04-11

Termination date

2020-06-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Greenville, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0616-2018