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 plasti
Summary
The FDA issued a Class II for Blemfree All Day Lotion (salicylic acid 0.5% w/w), packaged in a) 1 oz. 29 ML tu by Equibal Inc. Reason: CGMP Deviations: Manufactured without following Current Good Manufacturing Practises..
Details
Source
Drug Recall
External ID
D-0591-2024
Action Date
2024-07-17
Status
Terminated
Category
drug
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
Lot/Code Info: Lot # a) BF063221, exp. date 03/04/2025, BF097221, exp. date 04/07/2025, b) BF097221 exp date 04/07/2025
Quantity Affected: 90/1 oz. tubes and 248/4 oz. bottles
Reason for Recall
CGMP Deviations: Manufactured without following Current Good Manufacturing Practises.
Distribution
Nationwide in the USA via internet sales.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-06-26
Company
Unionville, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 61 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Equibal Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Equibal Inc have FDA actions?
This is the only FDA action we have on record for Equibal Inc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0591-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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