US/Silver Spring: Mylan Pharmaceuticals Inc., a Pittsburgh, Pennsylvania establishment, has recalled one (1) batch/lot of its Insulin Glargine (Insulin glargine- yfgn) Injection, 100 units/mL (U-100), packaged in 10 mL vials from the United States marketplace due to reported mislabeling, as follows:
Additional information:
According to the company, this drug product is not the branded Semglee vial but, in fact, the unbranded Insulin Glargine- yfgn. This batch is being recalled due to the potential for the label to be missing on some vials. The product information, batch number and expiry date information are present on the carton.
Filed under: Drugs, Insulin, Labeling or regulatory issues, Medical / Veterinary, US FDA | Tagged: 49502-393-80, Glargine, incorrect labelling hazard, Insulin, medical, Mylan Pharmaceuticals Inc., Recalls Direct RIN: 15769-20222, Semglee, US FDA, US Food and Drug Administration | Leave a comment »