FDA (Drugs) recall action 87214
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.
CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
The agency’s own wording, quoted from the enforcement report.
Ascend Laboratories LLC is recalling Cephalexin for Oral Suspension due to CGMP deviations involving unidentified impurities.
Ascend Laboratories is recalling Cephalexin for Oral Suspension because unidentified impurities were found at higher levels than allowed.