FDAApril 14, 2022drug
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
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content
What to do
FDA enforcement status: Terminated
Brands named
monarch pcmmonarch
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAHydroquinone USP, 4% Skin Bleaching Cream, Rx only, Net Wt 1 oz (28.35g), Manufactured for: Westminster Pharmaceuticals, LLC Nashville, TN 37217 NDC 69367-174-012021-09-23
- FDAFerretts IPS Iron Liquid Dietary Supplement Iron Protein Succinylate 40 mg (elemental iron) / 15 mL 8 oz. White Round PET 24/410 bottle2021-09-02
- FDASodium 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 117472021-09-01
- FDAHydroquinone, 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 52021-09-01
- FDAEndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5)2019-10-01
- FDAHoney Lavender, 1 oz, 2 oz, 4 oz, and 1-3 lb packages. An herbal tea, Taos, NM2019-08-01
- FDASandia Rose, 1 oz (28.4 g), 2 oz, 4 oz, and 1-3 lb packages. An herbal tea, Taos, NM2019-08-01
- FDAGinger Spice, 1 oz (28.4 g), 2 oz, 4 oz, and 1-3 lb packages. An herbal tea, Taos, NM2019-08-01
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