Hydroquinone USP, 4% Skin Bleaching Cream, Rx only, Net Wt 1 oz (28.35g), Manufactured for: Westminster Pharmaceuticals,
Summary
The FDA issued a Class II for Hydroquinone USP, 4% Skin Bleaching Cream, Rx only, Net Wt 1 oz (28.35g), Manufa by Monarch PCM, LLC. Reason: Finished product specification did not meet USP specifications..
Details
Source
Drug Recall
External ID
D-0855-2021
Action Date
2021-10-06
Status
Terminated
Category
drug
Product Description
Hydroquinone USP, 4% Skin Bleaching Cream, Rx only, Net Wt 1 oz (28.35g), Manufactured for: Westminster Pharmaceuticals, LLC Nashville, TN 37217 NDC 69367-174-01
Lot/Code Info: Lots: 21FP1743, 21FP1745 Exp. 05/2023
Quantity Affected: 11,419 tubes
Reason for Recall
Finished product specification did not meet USP specifications.
Distribution
TN
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-23
Company
Fort Worth, TX
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 107 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 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 (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-0855-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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