Abrams Royal Pharmacy Sterile Products - Recall - Lack of Sterility Assurance
UPDATED 12/21/2013 The 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.
Patients who were administered any sterile drug products produced and distributed by Abrams and have concerns should contact their health care professional.
AUDIENCE: Pharmacy, Consumer
ISSUE: Abrams Royal Pharmacy is voluntarily recalling all unexpired lots of sterile products dispensed nationwide due to concerns of lack of sterility assurance. All unexpired lots of sterile compounded products are subject to the recall. Sterile products are injectable medications, IVs, eye drops, pellet implants, nasal sprays, inhalation solutions, and eye ointments.
The recall was issued after a single, isolated report of an adverse event involving a patient in California who received a compounded medication from the pharmacy. Out of an abundance of caution, Abrams Royal is voluntarily recalling all sterile products within expiry. If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections.
All recalled products have a label that includes Abrams Royal Pharmacy’s name and phone as well as a lot number. While not every label contains an expiration date, consumers can call the pharmacy with the lot number and find out the expiration date.
BACKGROUND: The recalled products were distributed to health care facilities, physicians, and patients from June 17, 2013, through December 17, 2013.
RECOMMENDATION: Abrams Royal Pharmacy is notifying its customers by mail and is arranging for the return of all recalled medication. To return product or request assistance related to this recall, users should contact Abrams Royal at 214-349-8000, Monday through Friday, between 9:00 a.m. and 5:00 p.m. CST.
Customers that have product which is being recalled should stop using it and contact the pharmacy to arrange for return of unused product.
[12/21/2013 - News Release - FDA]
[12/18/2013 - Press Release - Abrams Royal Pharmacy]