FDA recall D-0387-2022

Mayne Pharma Inc · Class II · drug

Product

Lexette (halobetasol propionate) Topical Foam, 0.05% 50 g canisters, Rx ONLY, Distributed by: Mayne Pharma Greenville, NC 27834, NDC 51862-604-50

Reason for recall

CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam.

Distribution

Nationwide within the United States

Key facts

Status
Ongoing
Initiation date
2022-01-14
Report date
2022-01-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Greenville, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0387-2022