On January 25, 2017, Hospira, Inc. recalled one lot of Vancomycin Hydrochloride for Injection, USP (NDC: 0409-6510-01, Lot 591053A, Expiry Date 1NOV2017), to the hospital/retail level due to a confirmed customer report of the presence of particulate matter within a single vial. The product is packaged in a carton containing 1x100 mL vials. The lot was distributed from August 2016 through September 2016 in the United States.
If particulate is administered to a patient, it may result in local swelling, irritation of blood vessels or tissue, blockage of blood vessels, and/or low-level allergic response to the particulate. The risk is reduced by the possibility of detection, as the label contains a clear statement directing the physician to visually inspect the product for particulate matter and discoloration prior to administration.
Vancomycin Hydrochloride is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant staphylococci (MRSA).
See the FDA Safety Alert
See also the Recall
See also Medical Law Perspectives, June 2016 Report: How Risky is Going to the Hospital? The Dangers and Liabilities of Healthcare-Associated Infections
See also Medical Law Perspectives, October 2015 Report: Unclean, Unsterile, Unsafe: Risks of Injury from Unsterilized Medical Equipment
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication