Particulate Matter in Injectables: Main cause for Recalls

Abstract

Editorial Presence of foreign visible or sub-visible particulate matter in injectable/ parenteral formulations has been one of the most commonly seen reasons for recalls. FDA reported 22 % recalls for sterile injectable drugs in period of 2008-2012 caused due to presence of visible particles [1]. Recent 2014 list of FDA recalls include the products as mentioned in the Table 1 [2]. All injectables are mostly contaminated with some level of particulate matter. This Particulate matter is a critical quality attribute which has direct impact on product safety. Therefore, the United States Pharmacopoeia has defined the standards for particulate matter. These standards are established for all injectable preparations such as large-volume Injections for single-dose infusion and small-volume Injections, solutions for injection administered by intramuscular or subcutaneous route, except parenterals for use as irrigating solutions, radiopharmaceutical preparations and parenteral products for which the labeling specifies use of a final filter prior to administration [3,4].