Glass Delamination Woes Trigger FDA Advisory

Recent additional product recalls due to glass delamination, including injectables such as dexamethasone, 23.4% concentrated sodium chloride for injection, bacteriostatic water for injection, potassium phosphates, sodium thiosulfate and sodium bicarbonate, have triggered an advisory from the U.S. Food and Drug Administration (FDA). The advisory is designed to help pharmaceutical manufacturers prevent glass flakes from forming [...]

Drug Product Recalls Linked to Siliceous Flakes from Glass Containers

Glass is not inert and is particularly susceptible to chemical reactions at the surface. The glass formulation and manufacturing processes can influence the potential for leachables and/or glass flakes (delamination). The Na2O and K2O fluxes that are added to glass formulations reduce melting for forming glass but are weakly bonded and can leach into solutions contacting [...]

Glass Flakes in Drug Product Trigger Massive Recall

The recently initiated voluntary recall of certain lots of anemia drugs was due to potential contamination of products with glass flakes.  Over 324,000 vials of drug product were recalled. The products are indicated for the treatment of anemia related to HIV therapy, chronic renal failure and chemotherapy.The glass flakes, also known as siliceous flakes, are [...]