FDA (Drugs) recall action 87748
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.
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
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.
SigmaPharm Laboratories is recalling Asenapine sublingual tablets because they were manufactured with the wrong flavoring agent.
SigmaPharm Laboratories LLC is recalling Asenapine Sublingual Tablets because they were manufactured with the incorrect flavoring agent.