Sagent recalls Docetaxel Injection for particulate matter

Sagent is recalling two lots of Docetaxel injection in US. The recall follows a customer complaint for particulate matter from the stopper in the drug product. Docetaxel injection is in a class of medications called taxanes, used to treat certain type of cancers.

Particulate matter in injection vials is one of the major reasons for recall of injectable products. In current year till May 2024 alone there has been more than 9 recalls including from Pharma biggies like Pfizer / Hospira. The reasons for recalls range from silicone particles, particles from stopper, glass particles, floating white particles, black particles and so on. Sagent itself had recalled 4 lots of Methylprednisolone Acetate Injectable Suspension for potential black particles in April 2024. Particulate matter in intravenous injections can cause serious adverse events like blockage of blood vessels in the heart, lungs or brain which can cause stroke or life-threatening blood clot events

Particulates in injectables have serious patient safety concerns and controls for the same have to be built in through a comprehensive and holistic approach by the manufacturers. Potential sources for particulate matter could be Inherent, Intrinsic and /or Extrinsic – Manufacturing process and stability of the product, Materials (Raw Materials, Packing Materials), Container closure system, Manufacturing Equipment & Facility, Operator practices. Identify potential sources for particulate contamination and establish appropriate controls. Implement robust Visual Inspection programme with qualified inspectors. The USFDA draft guidance Inspection of Injectable Products for Visible Particulates) provides a comprehensive overview on Visible particulate controls, potential sources, inspection techniques.

References:

• Sagent Recall Announcement for Docetaxel Injection
• Recall of Injectable products for Particulate Matter in 2024:
  • Parr Pharmaceuticals (Treprostinil Injection for Silicone Particulates), Denver Solutions (Lidocaine HCL & Phenylephrine HCL injection for glass delamination) Denver Solutions (Moxifloxacin injection for glass delamination), Eugia US LLC (Methocarbamol Injection for white particulates). Pharma Major Pfizer also recalled 4 drug products for particulate matter, identified as glass (Bleomycin for Injection, Atropine Sulfate Injection, Sodium Bicarbonate Injection)
• Additional Reference:
  • USFDA 483 / Intas / May 2023 /Manipulation of Visual Inspection records, Particles in injection vials.