Injectables, HRT Products Recalled for Sterility Concerns

Troy Brown

Disclosures

August 01, 2013

Beacon Hill Medical Pharmacy, dba Rxtra Solutions, is voluntarily recalling all lots of 135 sterile injectables and hormone replacement therapy products nationwide to the user level because of concerns about sterility assurance that were raised by the US Food and Drug Administration (FDA), the company announced in a press release today.

Serious and sometimes life-threatening infections can result from microbial contamination of products that are intended to be sterile. "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," the company explained in the press release.

The recalled products are prescribed by physicians to patients receiving intravenous (IV) solutions and hormone replacement therapy. A complete list can be found in the press release.

The products consist of liquid solution, suspension, or lyophilized powder packaged in clear or amber sterile injectable vials that range in size from 1 to 100 mL and are packaged in either individual prescription vials for patients or cardboard boxes with multiple single units.

Lot numbers of the affected products (listed on product labels) include numbers starting with codes 01012013@1 to 07262013@99. Additional information including drug name, strength, and quantity of product; lot number; recommended use-by date; product ingredients; storage instructions; and the facility information and address are listed on the product labels.

The products were distributed nationwide to hospitals, clinics, and patients in response to orders placed directly by telephone or fax to the Beacon Hill Medical Pharmacy facility in Southfield, Michigan. The company has been notifying customers by telephone since July 26, 2013, and will begin sending recall mailers including formal letters. Beacon Hill will continue calling patients and providers and will schedule office visits with physicians to discuss the matter further.

The company is arranging for all recalled products to be returned. Healthcare providers, hospital staff, and patients are being advised to immediately check their inventories, identify and stop using affected products, and contact Beacon Hill Medical Pharmacy at 800-518-9831 for further assistance.

"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," the company notes in the statement. "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."

The company has formed a task force of pharmacists and personnel to coordinate a product replacement transition.

Consumers with questions are instructed to contact Beacon Hill at 800-518-9831 during the business hours of 10 am and 6 pm Eastern Standard Time. Patients are instructed to contact their physician or healthcare provider if they believe they have experienced any problems related to these products.

Adverse reactions or quality issues related to the use of these products may be reported to MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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