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.
Abrams Royal Pharmacy has begun 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 begin_of_the_skype_highlighting 214-349-8000 FREE end_of_the_skype_highlighting , 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. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using these products. Adverse reactions may be reported to the FDA’s MedWatch program via:
Online:www.fda.gov/medwatch/report.htmMail : use postage-paid, pre-addressed Form FDA 3500 atwww.fda.gov/MedWatch/getforms.htm .Fax: 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.