Risk Statement: For patients receiving treatment with more than one type of insulin (e.g., both short and long-acting insulin), a missing label on Insulin Glargine pens could lead to a mix-up of products/strengths, which may result in less optimal glycemic control (either high or low blood sugar) which could result in serious complications. This batch is being recalled due to the potential for the label to be missing on some pens. This product is not the branded Semglee® pen but the unbranded Insulin Glargine-yfgn pens. The list of affected brands can be found on the FDA website.ĭate: Recall: Insulin Glargine (Insulin glargine-yfgn) Injection Pens, 100 units/mL (U-100) Details:įOR IMMEDIATE RELEASE - PITTSBURGH – J– Mylan Pharmaceuticals Inc., a Viatris company, is voluntarily recalling one batch of Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens which are packaged in cartons of five pens to the consumer level. The product is packaged in a 10 oz clear round plastic bottle. The product is used for relief of occasional constipation (irregularity) and generally produces bowel movement in ½ to 6 hours. Vi-Jon, LLC is in the process of investigating this report. To date, Vi-Jon, LLC has received one report of an adverse reaction potentially related to this recall. Risk Statement: Immunocompromised patients, who consume this product, may be at increased risk for invasive infections caused by Gluconacetobacter liquefaciens that could lead to serious, life-threatening adverse health consequences. The recall was initiated after 3rd Party and Vi-Jon, LLC microbial testing identified the presence of Gluconacetobacter liquefaciens. Vi-Jon, LLC is expanding its voluntary recall to include all lots of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor, 10 FL OZ (296 mL) within expiry to the consumer level. Date: Recall: Vi-Jon, LLC Expands Voluntary Nationwide Recall of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor Due to Microbial Contamination Details: