FDA (Drugs) recall action 85833
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.
Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
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.
Crown Laboratories is recalling 62,274 tubes of Nystatin Cream because the product failed potency testing at the 9-month interval.
Crown Laboratories is recalling Nystatin Cream, USP, because the product failed potency testing at the 9-month interval.