Blemfree All Day Lotion (salicylic acid 0.5% w/w), packaged in a) 1 oz. 29 ML tube NDC:53228-003-...
FDA Recall #D-0591-2024 — Class II — June 26, 2024
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.
Recalling Firm
Equibal Inc — Unionville, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
90/1 oz. tubes and 248/4 oz. bottles
Distribution
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
Status
Completed
Voluntary / Mandated
Voluntary: Firm initiated