FDA (Drugs) recall action 94737
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.
Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)
CGMP Deviations
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.
Suntegrity IMPECCABLE SKIN sunscreen foundation is recalled for microbial contamination with Aspergillus Sydowii mold. Consumers should discontinue use immediately.
Suntegrity IMPECCABLE SKIN sunscreen foundation is being recalled due to Current Good Manufacturing Practice (CGMP) deviations. The recall involves 8,202 tubes distributed nationwide and internationally.