FDA (Drugs) recall action 96912
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.
Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.
The agency’s own wording, quoted from the enforcement report.
Ascend Laboratories is recalling Cephalexin for Oral Suspension due to failed impurity specifications identified during stability testing. An out-of-specification result for Cephalexin Glucose Adduct was observed at six months.
Ascend Laboratories is recalling Cephalexin for Oral Suspension due to an out-of-specification result in impurity testing that identified Cephalexin Glucose Adduct during stability analysis.