GSK recalls 427,000 antibiotics after contamination scare
pharmafile | September 15, 2015 | News story | Manufacturing and Production |Â Â Bactroban, FDA, GSK, manufacturing, product recalls, production, recallsÂ
GlaxoSmithKline has had to recall more than 427,000 tubes of creams and ointments due to potential penicillin cross-contamination and the presence of particulates.
An FDA enforcement report reveals the UK-based company is recalling 427,513 tubes of its Bactroban (mupirocin calcium 2% creams) cream and Bactroban nasal ointment.
The nationwide Class II recalls include 22 lots in total: six of Bactroban nasal ointment, one of Bactroban ointment, three of Bactroban cream, and 12 of mupirocin calcium cream.
The active ingredient in all the products is mupirocin, an antibacterial used to treat skin conditions such as impetigo.
All of the products were produced at GSK’s plant in Worthing, England. It is one of the oldest facilities in the company’s network, and workplace to around 1,000 employees.
GSK says it initiated the recall voluntarily after discovering that the products’ active pharmaceutical ingredient may have been contaminated with penicillin and foreign substances during the manufacturing process. It added that employees at Worthing were now taking ‘corrective and preventative actions.’
The Worthing plant has been producing medicines since 1960, but this latest recall is not the first time the facility has come under scrutiny.
The FDA issued a warning in 2011 after Worthing failed to meet quality standards during an inspection, which found a number of violations, including a lack of written procedures designed to prevent microbiological contamination of sterile drug products.
Joel Levy
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