FDA (Drugs) recall action 67881
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.
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
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.
American Health Packaging is recalling HydrOXYzine HCl Tablets because the active pharmaceutical ingredient came from an unapproved source.
American Health Packaging is recalling HydrOXYzine HCl 50 mg tablets because the active ingredient came from an unapproved source.