FDA (Drugs) recall action 63891
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.
Presence of Foreign Substance(s): There is a potential for foreign particulate matter in the API.
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.
Physicians Total Care is recalling Tetracycline 500 mg capsules due to a potential for foreign particulate matter in the active pharmaceutical ingredient.
Physicians Total Care is recalling Tetracycline 250 mg capsules due to a potential for foreign particulate matter in the active pharmaceutical ingredient.