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Monarch PCM, LLC

Monarch PCM, LLC Recalls

All product recalls associated with Monarch PCM, LLC.

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

Apr 2022

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–5 of 5 recalls

Phenobarbital Elixir (Monarch PCM) – Alcohol Content Excess (2022)

Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content

Class IIILow

FDAApr 14, 2022TN• Monarch PCM, LLC

Hydroquinone Skin Bleaching Cream (Monarch) – USP Specification Failure (2021)

Finished product specification did not meet USP specifications.

Class IIModerate

FDASep 23, 2021TN• Monarch PCM, LLC

Ferretts Iron Supplement (Monarch) – Stability Issue (2021)

Stability is out of spec at 81% for 3 month time period.

Class IIModerate

FDA

Sep 2, 2021

• Monarch PCM, LLC

Hydroquinone Skin Cream (Monarch) – Subpotency Issue (2021)

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

Class IIILow

FDASep 1, 2021OH, TN• Monarch PCM, LLC

Sodium Sulfacetamide Wash (Monarch) – Subpotency Issue (2021)

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

Class IIILow

FDASep 1, 2021OH, TN• Monarch PCM, LLC