US/Silver Spring: Beacon Hill Pharmacy doing business as Rxtra Solutions recalls numerous lots of Sterile Medical Products due to microbial contamination hazard. FDA: http://ht.ly/nDXAq
Direct link: http://www.fda.gov/Safety/Recalls/ucm363284.htm
Additional information:
The US Food and Drug Administration (“FDA”) reports approximately 135 Sterile Medical Products are subject to this recall. The complete list can be found at the above links.
According to the FDA, the recalled 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.
Microbial contamination of products intended to be sterile can lead to serious infections, which may have life-changing or even fatal consequences. 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.
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Recalls Direct RIN: 2013-2351
About the Recalls Direct service: http://wp.me/P2bVty-2
Visit the Living Safely site: http://www.LivingSafely.org/
E. & O. E.
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Filed under: Bacterial or viral contamination, Medical / Veterinary, Mold / mould hazard, US FDA | Tagged: Beacon Hill Pharmacy, microbial contamination hazard, Recalls Direct RIN: 2013-2351, Rxtra Solutions, Sterile Medical Products | Leave a comment »