FDA (Drugs) recall action 77601
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.
Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg
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.
Apace KY LLC is recalling 1,483 cartons of Amantadine HCl Capsules because they were mislabeled and contain Cyclobenzaprine HCl tablets instead.
Apace KY LLC is recalling Cyclobenzaprine HCl 5 mg tablets because cartons were mislabeled as Amantadine HCl 100 mg capsules.