FDA (Drugs) recall action 76873
The FDA (Drugs) publishes a recall like this one as 4 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 4 pages.
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
The agency’s own wording, quoted from the enforcement report.
Medisca, Inc. is recalling Estradiol, USP Bulk (Hemihydrate) in 25 g and 100 g bottles due to cGMP deviations identified during an FDA inspection.
Medisca, Inc. is recalling Estriol, USP (Micronized) Bulk in various bottle sizes due to cGMP deviations identified during an FDA inspection.
Medisca, Inc. is recalling Estradiol, USP (Hemihydrate) (Micronized) API products due to cGMP deviations identified during a recent FDA inspection.
Medisca, Inc. is recalling Estrone, USP Bulk in various bottle sizes due to current Good Manufacturing Practice (cGMP) deviations identified during an FDA inspection.