Monarch PCM recalls
FDA enforcement reports naming Monarch PCM, LLC as the recalling firm.
- Recall reports
- 5
- Class I (serious)
- 0
- Most recent report
- May 25, 2022
- May 25, 2022Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only, Manufactured…Drug · Monarch PCM, LLCDoes Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol contentClass III
- Oct 6, 2021Ferretts IPS Iron Liquid Dietary Supplement Iron Protein Succinylate 40 mg (elemental i…Food · Monarch PCM, LLCStability is out of spec at 81% for 3 month time period.Class II
- Oct 6, 2021Hydroquinone USP, 4% Skin Bleaching Cream, Rx onlyDrug · Monarch PCM, LLCFinished product specification did not meet USP specifications.Class II
- Sep 29, 2021Sodium Sulfacetamide, 10%, Wash, packaged in bottles: a) 6 fl oz (177 mL) NDC 42808-103…Drug · Monarch PCM, LLCSubpotency: one product for active ingredient assay and another one for preservative assayClass III
- Sep 29, 2021Hydroquinone, USP, 4% Skin Bleaching Cream, packaged in 1 oz (28Drug · Monarch PCM, LLCSubpotency: one product for active ingredient assay and another one for preservative assayClass III