Monarch PCM, LLC: Drug Recall

Recall #D-0818-2021 · 09/01/2021

Class III: Low Risk

Recall Details

Recall Number: D-0818-2021
Classification: Class III
Product Type: Drug
Recalling Firm: Monarch PCM, LLC
Status: Terminated
Date Initiated: 09/01/2021
Location: Fort Worth, TX, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 6305 tubes

Reason for Recall

Subpotency: one product for active ingredient assay and another one for preservative assay

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

Distribution Pattern

OH, TN

Other Recalls by Monarch PCM, LLC

Class III: Low Risk 04/14/2022

Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content
Class II: Risk 09/23/2021

Finished product specification did not meet USP specifications.
Class III: Low Risk 09/01/2021

Subpotency: one product for active ingredient assay and another one for preservative assay

View all recalls by Monarch PCM, LLC →

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.