D-0591-2024 Class II

Recalled by Equibal Inc — Unionville, NY

Recall Details

Product Type
Drugs
Report Date
July 17, 2024
Initiation Date
June 26, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
90/1 oz. tubes and 248/4 oz. bottles

Product Description

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 Pattern

Nationwide in the USA via internet sales.

Code Information

Lot # a) BF063221, exp. date 03/04/2025, BF097221, exp. date 04/07/2025, b) BF097221 exp date 04/07/2025