Equibal Inc: Drug Recall

Recall #D-0591-2024 · 06/26/2024

Class II: Risk

Recall Details

Recall Number
D-0591-2024
Classification
Class II
Product Type
Drug
Recalling Firm
Equibal Inc
Status
Completed
Date Initiated
06/26/2024
Location
Unionville, NY, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
90/1 oz. tubes and 248/4 oz. bottles

Reason for Recall

CGMP Deviations: Manufactured without following Current Good Manufacturing Practises.

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

Distribution Pattern

Nationwide in the USA via internet sales.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.