FDA (Drugs) recall action 81784
The FDA (Drugs) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
US Pharmaceuticals is recalling Soothe & Cool Protect Moisture Guard Skin Protectant due to out-of-specification microbial counts in purified water.
US Pharmaceuticals is recalling Hydrocortisone Cream Intensive Healing due to out-of-specification microbial counts in purified water.
US Pharmaceuticals is recalling Medline Remedy Barrier Skin Protectant Ointment due to out-of-specification microbial counts in purified water.