Home / Recalls / Monarch PCM, LLC / D-0818-2021

D-0818-2021 Class III Terminated

Recalled by Monarch PCM, LLC — Fort Worth, TX

FDA drug recall D-0818-2021 was initiated by Monarch PCM, LLC on Sep 1, 2021 and is designated Class III. Reason for recall: Subpotency: one product for active ingredient assay and another one for preservative assay The recall status is terminated (terminated Jun 21, 2023). Affected quantity: 6305 tubes.

Recall Details

Product Type: Drugs
Report Date: Sep 29, 2021
Initiation Date: Sep 1, 2021
Termination Date: Jun 21, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 6305 tubes

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

Reason for Recall

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

Distribution Pattern

OH, TN

Code Information

Lot: 21FP1731 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-0818-2021
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.

Other recalls by Monarch PCM, LLC

D-0878-2022 Class III — Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only… (Apr 14, 2022)
D-0855-2021 Class II — Hydroquinone USP, 4% Skin Bleaching Cream, Rx only, Net Wt 1 oz (28.35g)… (Sep 23, 2021)
F-1020-2021 Class II — Ferretts IPS Iron Liquid Dietary Supplement Iron Protein Succinylate 40 mg… (Sep 2, 2021)
D-0817-2021 Class III — Sodium Sulfacetamide, 10%, Wash, packaged in bottles: a) 6 fl oz (177 mL) NDC… (Sep 1, 2021)