FDA (Drugs) recall action 86285
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.
Sub-Potent Drug: Out of specification test results for potency (below specification).
CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
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.
Teva Pharmaceuticals is recalling Cephalexin for Oral Suspension because test results showed the drug was below the required potency specification.
Teva Pharmaceuticals is recalling specific lots of Cephalexin for Oral Suspension because current Good Manufacturing Practice deviations may cause active ingredient levels to fall outside specification limits.
Teva Pharmaceuticals is recalling Cephalexin for Oral Suspension because current Good Manufacturing Practice deviations may cause active ingredient levels to fall outside specification limits.