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Monarch PCM, LLC FDA Recalls
5 recalls on file across drugs, food, 0 of them Class I and 0 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals,Class IIIApr 14, 2022Does Not Meet USP or OTC Monograph: Product exceeds USP spec |
| Hydroquinone USP, 4% Skin Bleaching Cream, Rx only, Net Wt 1 oz (28.35g), Manufactured for: Westminster Pharmaceuticals,Class IISep 23, 2021Finished product specification did not meet USP specificatio |
| Ferretts IPS Iron Liquid Dietary Supplement Iron Protein Succinylate 40 mg (elemental iron) / 15 mL 8 oz. White Round PEClass IISep 2, 2021Stability is out of spec at 81% for 3 month time period. |
| Sodium Sulfacetamide, 10%, Wash, packaged in bottles: a) 6 fl oz (177 mL) NDC 42808-103-06 UPC 3 42808 10306 5; b) 12 flClass IIISep 1, 2021Subpotency: one product for active ingredient assay and anot |
| Hydroquinone, USP, 4% Skin Bleaching Cream, packaged in 1 oz (28.35g) tube, Rx only, Manufactured for: Westminster PharClass IIISep 1, 2021Subpotency: one product for active ingredient assay and anot |