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Monarch PCM, LLC

Recalls

Recalls by year

A bar chart of the number of recalls naming this company by year.

Recalls by year
YearRecalls
20214
20221
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FDA Recall Terminated Historical recordClass III

Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC Tampa, FL 33624, NDC 69367-172-16

by Monarch PCM, LLC

Reason
Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content
Published
May 25, 2022
Distribution
TN only

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FDA Recall Terminated Historical recordClass II

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

by Monarch PCM, LLC

Reason
Finished product specification did not meet USP specifications.
Published
October 6, 2021
Distribution
TN

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FDA Recall United States Terminated Historical recordClass II

Monarch PCM, LLC

Product
Ferretts IPS Iron Liquid Dietary Supplement Iron Protein Suc…
Reason
Stability is out of spec at 81% for 3 month time period.
Published
October 6, 2021
Distribution
UT

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FDA Recall Terminated Historical recordClass III

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

by Monarch PCM, LLC

Reason
Subpotency: one product for active ingredient assay and another one for preservative assay
Published
September 29, 2021
Distribution
OH and TN

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FDA Recall Terminated Historical recordClass III

Sodium Sulfacetamide, 10%, Wash, packaged in bottles: a) 6 fl oz (177 mL) NDC 42808-103-06 UPC 3 42808 10306 5; b) 12 fl oz (354.8 mL) NDC 42808-103-12 UPC 3 42808 10312 6, Rx only, Manufactured in the U.S.A. for Exact-Rx, Inc., Melville, NY 11747

by Monarch PCM, LLC

Reason
Subpotency: one product for active ingredient assay and another one for preservative assay
Published
September 29, 2021
Distribution
OH and TN

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Showing 1–5 of 5 results

This page lists recalls that name Monarch PCM, LLC as the recalling firm in the official source notice. It is not a safety rating, ranking, or statement that the company acted negligently. Read the full medical disclaimer.