Monarch PCM, LLC

FDA Regulatory Profile

Summary

Total Recalls
5
510(k) Clearances
0
Inspections
3
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0878-2022Class IIIPhenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only, Manufactured for: WestminsApril 14, 2022
D-0855-2021Class IIHydroquinone USP, 4% Skin Bleaching Cream, Rx only, Net Wt 1 oz (28.35g), Manufactured for: WestminsSeptember 23, 2021
F-1020-2021Class IIFerretts IPS Iron Liquid Dietary Supplement Iron Protein Succinylate 40 mg (elemental iron) / 15 mL September 2, 2021
D-0818-2021Class IIIHydroquinone, USP, 4% Skin Bleaching Cream, packaged in 1 oz (28.35g) tube, Rx only, Manufactured fSeptember 1, 2021
D-0817-2021Class IIISodium Sulfacetamide, 10%, Wash, packaged in bottles: a) 6 fl oz (177 mL) NDC 42808-103-06 UPC 3 428September 1, 2021