FDA (Drugs) recall action 62383
The FDA (Drugs) publishes a recall like this one as 5 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 5 pages.
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
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.
Watson Laboratories is recalling 8,254 bottles of Loxapine Capsules 5mg because an outdated patient outsert was used during packaging.
Watson Laboratories is recalling 7,262 bottles of Loxapine Succinate Capsules because an outdated patient outsert was used during packaging.
Watson Laboratories is recalling 18,902 bottles of Loxapine 50mg capsules because an outdated patient outsert was used during packaging.
Watson Laboratories Inc. is recalling Loxapine Capsules because an outdated version of the patient outsert was used during packaging.
Watson Laboratories Inc. is recalling Loxapine Capsules because an outdated patient outsert was used during packaging.