FDA Announces Voluntary Recall from Abrams Royal Compounding Pharmacy
Abrams Royal Pharmacy is recalling all unexpired lots of sterile products dispensed in the US.
FDA is alerting hospitals, healthcare professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, Texas, the agency announced in a press release. The recalled products include injectable medications, intravenous (IV) injections, eye drops, pellet implants, nasal sprays, inhalation solutions, and eye ointments that were distributed between June 17, 2013 and Dec. 17, 2013.
FDA is aware of one adverse event associated with mineral IV injection produced by Abrams’ lot number 11142013@74. A patient who received this product was admitted to a hospital in California and had blood cultures that tested positive for Stenotrophomonas maltophilia, a gram-negative bacterium that can cause many types of infections. These include respiratory infections such as pneumonia, bloodstream infections, and meningitis. In addition, Abrams identified a similar gram-negative bacterium in the same lot of mineral IV injection.
FDA Reopens Comment Period on HCP Immunogenicity Risk of Follow-on Recombinant Peptides
January 2nd 2025FDA is reopening the comment period for the Federal Register Notice, “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments”, until March 3, 2025.
