June 2024 FDA Recall Blemfree by Equibal Inc
D-0591-2024 - CGMP Deviations
This Class II drug recall was voluntarily initiated by Equibal Inc on June 26, 2024 for the product Blemfree. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0591-2024
CGMP Deviations: Manufactured without following Current Good Manufacturing Practises.
06-26-2024
07-17-2024
90/1 oz. tubes and 248/4 oz. bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Equibal Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA via internet sales.
04-07-2026
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# a) BF063221, exp. date 03/04/2025, BF097221, exp. date 04/07/2025, b) BF097221 exp date 04/07/2025
