FDA (Drugs) recall action 76443
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.
Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an organic impurity.
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.
L. Perrigo Company is recalling Salicylic Acid Cream, 6%, due to an out-of-specification organic impurity. The FDA classified this as a Class III recall.
L. Perrigo Company is recalling Salicylic Acid Shampoo, 6%, because the active ingredient failed impurity specifications.