J&J recalls Procrit lot with cracked vials
This article was originally published in Scrip
Johnson & Johnson's Ortho Biotech division has recalled one manufacturing lot of its erythropoiesis-stimulating agent Procrit (epoetin-alfa) in the US owing to cracks in the necks of some vials. More than 44,000 vials in the affected lot were distributed between April 15th and July 17th. The company said it had not received any reports of adverse events or complaints, but cracked vials may lose their sterility and should not be used for subcutaneous or intravenous injection. The amount of Procrit being withdrawn represents a very small proportion of the total product in the distribution channel and J&J does not anticipate a supply disruption.
You may also be interested in...
Agency wants to ensure patients ‘aren’t unnecessarily or unfairly scared off or intimidated’ from taking biosimilars, Office of Therapeutic Biologics and Biosimilars' acting policy director Eva Temkin tells the FDA/CMS Summit; Temkin says recent guidance on biosimilar insulins shows agency is trying to be flexible on interchangeability data requirements.
AstraZeneca and Merck seek to add a pancreatic cancer indication for olaparib, while Merck has hopes of broadening pembrolizumab’s use in bladder cancer; two-day Oncologic Drugs Advisory Committee meeting also will include reviews of Celgene’s luspatercept in myelodysplastic syndromes-related anemia and Epizyme’s tazemetostat for epithelioid sarcoma.
Clinicians and sponsors want the US FDA to open up antibacterial labeling to include more data on efficacy against resistant pathogens and in other body sites, but regulatory restrictions may require a workaround in the form of rapid, peer-to-peer communications about the data on new products.