Thursday, January 02, 2014

Abrams Royal compounding pharmacy recalls all sterile products after adverse event, FDA reports

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.

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.

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.

The recalled products were distributed to health care facilities, physicians, and patients from June 17, 2013, through December 17, 2013.

 http://www.fda.gov/Safety/Recalls/ucm379313.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery