FDA recall D-0591-2024

Equibal Inc · Class II · drug

Product

Blemfree All Day Lotion (salicylic acid 0.5% w/w), packaged in a) 1 oz. 29 ML tube NDC:53228-003-01 b) 4 OZ 118ML plastic bottle, UPC 7 01450 90008 6, NDC # 53228-002-01, Equibal Labs, Inc

Reason for recall

CGMP Deviations: Manufactured without following Current Good Manufacturing Practises.

Distribution

Nationwide in the USA via internet sales.

Key facts

Status
Terminated
Initiation date
2024-06-26
Report date
2024-07-17
Termination date
2026-04-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Unionville, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0591-2024