Home / Recalls / Monarch PCM, LLC / D-0855-2021

D-0855-2021 Class II Terminated

Recalled by Monarch PCM, LLC — Fort Worth, TX

FDA drug recall D-0855-2021 was initiated by Monarch PCM, LLC on Sep 23, 2021 and is designated Class II. Reason for recall: Finished product specification did not meet USP specifications. The recall status is terminated (terminated Jun 23, 2023). Affected quantity: 11,419 tubes.

Recall Details

Product Type: Drugs
Report Date: Oct 6, 2021
Initiation Date: Sep 23, 2021
Termination Date: Jun 23, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 11,419 tubes

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

Reason for Recall

Finished product specification did not meet USP specifications.

Distribution Pattern

Code Information

Lots: 21FP1743, 21FP1745 Exp. 05/2023

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0855-2021
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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