FDA (Drugs) recall action 67103
The FDA (Drugs) publishes a recall like this one as 3 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 3 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.
KVK-Tech, Inc. is recalling 104,551 bottles of Hydroxyzine Hydrochloride tablets because the active ingredient came from an unapproved source.
KVK-Tech, Inc. is recalling 249,096 bottles of Hydroxyzine Hydrochloride tablets because the active pharmaceutical ingredient was sourced from an unapproved supplier.
KVK-Tech, Inc. is recalling 14,664 bottles of Hydroxyzine Hydrochloride 10 mg tablets because the active ingredient came from an unapproved source.