FDA (Drugs) recall action 64640
The FDA (Drugs) publishes a recall like this one as 2 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 2 pages.
Lack of Assurance of Sterility; potential for mold contamination
Non-Sterility; mold contamination
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.
Med Prep Consulting, Inc. is recalling all compounded products due to a lack of assurance of sterility and potential mold contamination.
Med Prep Consulting is recalling 403,883 bags of Magnesium Sulfate 2 grams in Dextrose 5% for Injection due to non-sterility and mold contamination.