The FDA has classified a recall initiated by Mylan Pharmaceuticals for Isotretinoin Capsules, USP 40 mg, as a Class II recall. This designation indicates that the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse health consequences is remote. The specific issue cited is the product failing its dissolution specifications. The affected product was manufactured for Mylan Pharmaceuticals Inc. and distributed nationwide in the US.

This recall requires immediate attention from distributors and pharmacies that may have received the affected product. While the FDA classifies this as Class II, indicating a lower risk than Class I recalls, entities holding this product should review their inventory and follow established recall procedures. Mylan Pharmaceuticals is responsible for managing the recall process, including notifying customers and potentially retrieving the affected product. Compliance officers should ensure their organizations have procedures in place to identify and segregate recalled products.