Southfield, MI, Beacon Hill Medical Pharmacy d/b/a/ Rxtra Solutions (Beacon Hill) is voluntarily recalling all lots of certain sterile products to the user level.
There is a question of sterility assurance for the affected products raised by the FDA.
Microbial contamination of products intended to be sterile can lead to serious infections, which may be life threatening.
Beacon Hill has not received any reports of adverse events related to this recall and to date, there is no evidence of contamination in the recalled products or any previously prepared products.
Physicians prescribe these products to patients receiving IV solutions and hormone replacement therapy.
To see a complete list of sterile injectable products compounded by Beacon Hill/Rxtra Solutions prescribed by physicians to individual patients click here.
These products are packaged in clear or amber sterile injectable vials ranging in size of 1 ml to 100 ml containing liquid solution, suspension or lyophilized powder.
The products are packaged in either individual patient prescription vials or single units in a cardboard box container.
The products can be identified via the label format, which will include lot numbers initiating with code 01012013@1 to 07262013@99.
The vials will contain a label indicating the drug name, strength, and quantity of product in the vial, the lot number with the codes indicated above, and a recommended use by date, product ingredients, storage instructions and the facility information and address.
A sample vial label and prescription label is attached that includes the exact format for all products dispensed.
The products were distributed nationwide to outlets including hospitals, clinics, and patients who have received orders by directly placing phone calls or faxed prescriptions to the Beacon Hill Medical pharmacy facility in Southfield, Michigan.
Beacon Hill began notifying its customers on July 26th 2013 via telephone, and will begin initiating recall mailers including formal letters, and will continue to call its patients and providers, and schedule office visits to discuss with physicians further.
Beacon Hill is arranging for return of all recalled products. Healthcare providers, hospital staff and patients should immediately check their inventory, identify products in their possession, which are being recalled, stop utilizing product and contact Beacon Hill Medical Pharmacy at 800.518.9831 to further assist with product replacement, continuity of care and further instructions on product return.
Beacon Hill recognizes FDA's observations of sterile practices and 211 guidelines and has already initiated its facility upgrade in an effort to deliver at the highest manufacturing standard.
Beacon Hill has initiated testing on products in the recall in quarantine in an effort to assess its validation process of prior sterility practices and will continue to cooperate with the FDA to establish 211 guided standards of practice.
Beacon Hill is dedicated to this voluntary recall and has set up a task force of pharmacists and personnel ready to establish a transition for product replacement and urges patients to contact the pharmacy for any assistance.
Consumers with questions regarding this recall can contact Beacon Hill by calling 800.518.9831 during the business hours of 10 am and 6 pm eastern standard time.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.