17th January 2020 Editorial by: Paul Carton
Fagron Recalls 30 Lots of Anaesthetic Due to Bacillus spp. Contamination
Fagron Inc., a pharmaceutical compounding company, has voluntarily recalled over 30 lots of a topical anaesthetic after the FDA identified Bacillus fortis/Geobacillus toebii, Bacillus spp, and Bacillus circulans as contaminants in a non-sterile ingredient packaged with the anaesthetic. The product, LETS GEL KIT Convenience pack, distributed to pharmacists and hospitals, contains the non-sterile base component Suturagel Methylcellulose, which is a specially formulated gel to minimize medication run-off. This particular ingredient was found to contain the contaminants after an FDA inspection.
The FDA issued this recall in November 2019 for products that have expiration dates up to February 2021: "This non-sterile product has the potential to result in an increased chance of infection at the site of administration during open wound care. The use of this or other non-sterile products in wound treatment may increase the risk of infection, especially for immunocompromised patients, the elderly or children". Fagron Inc. is notifying its distributors and customers by phone, e-mail, and/or letter and is arranging for return of all recalled products. Hospitals, pharmacies and distributors that have LETS GEL KIT Convenience Packs which are being recalled should quarantine this material.
Bacillus species are widely distributed throughout the environment. Its spores are resistant to disinfectants, sterilization, radiation, desiccation and efforts to destroy them through high or low temperatures. This makes them a significant contamination challenge for manufacturers of medical supplies, consumer products and even food products.
In the same week as the recall notice, Fagron was given another federal reprimand. On November 7th 2019, The Department of Justice announced that Fagron Holding USA LLC (Fagron) had agreed to pay $22.05 million to resolve allegations concerning the establishment of false and inflated Average Wholesale Prices (AWPs) by its wholly-owned subsidiary Freedom Pharmaceuticals Inc. (Freedom) for active pharmaceutical ingredients used in compound prescriptions. Freedom’s pricing scheme caused pharmacies that purchased Freedom’s compound ingredients to submit false prescription claims to the Defense Health Agency, which administers the TRICARE Program for the Department of Defense and the Department of Labor’s Office of Workers Compensation Programs (federal healthcare programs).
Date Published: 17th January 2020
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