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

D-0818-2021 Class III Terminated

Recalled by Monarch PCM, LLC — Fort Worth, TX

Recall Details

Product Type
Drugs
Report Date
September 29, 2021
Initiation Date
September 1, 2021
Termination Date
June 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

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, Manufa (April 14, 2022)
  • D-0855-2021 Class II — Hydroquinone USP, 4% Skin Bleaching Cream, Rx only, Net Wt 1 oz (28.35g), Manufa (September 23, 2021)
  • F-1020-2021 Class II — Ferretts IPS Iron Liquid Dietary Supplement Iron Protein Succinylate 40 mg (elem (September 2, 2021)
  • D-0817-2021 Class III — Sodium Sulfacetamide, 10%, Wash, packaged in bottles: a) 6 fl oz (177 mL) NDC 42 (September 1, 2021)