Hydroquinone, USP, 4% Skin Bleaching Cream, packaged in 1 oz (28.35g) tube, Rx only, Manufactured for: Westminster Phar
Summary
The FDA issued a Class III for Hydroquinone, USP, 4% Skin Bleaching Cream, packaged in 1 oz (28.35g) tube, Rx o by Monarch PCM, LLC. Reason: Subpotency: one product for active ingredient assay and another one for preservative assay.
Details
Source
Drug Recall
External ID
D-0818-2021
Action Date
2021-09-29
Status
Terminated
Category
drug
Product Description
Hydroquinone, USP, 4% Skin Bleaching Cream, packaged in 1 oz (28.35g) tube, Rx only, Manufactured for: Westminster Pharmaceuticals, LLC Nashville, TN 37217, NDC 69367-174-01 UPC 3 69367 17401 5
Lot/Code Info: Lot: 21FP1731 Exp 05/2023
Quantity Affected: 6305 tubes
Reason for Recall
Subpotency: one product for active ingredient assay and another one for preservative assay
Distribution
OH, TN
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-01
Company
Fort Worth, TX
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 42 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Monarch PCM, LLC has 5 FDA actions in our database, including 5 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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 (Monarch PCM, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Monarch PCM, LLC have FDA actions?
Monarch PCM, LLC has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0818-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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