UPDATED: GSK recalls more than 425K tubes of antibiotic cream


Several years ago, GlaxoSmithKline ($GSK) put a new emphasis on skin care products, even setting up a dermatology manufacturing center of excellence in the U.K. But its manufacturing of its Bactroban products has proven to be less than excellent of late, leading to the recall of more than a quarter of a million tubes of antibiotic cream that may be contaminated.

According to the most recent FDA Enforcement Report, the U.K. drugmaker is recalling 427,513 tubes of its Bactroban (mupirocin calcium) cream and Bactroban Nasal Ointment in different sizes. Mupirocin calcium cream is an antibiotic used to treat skin infections such as impetigo. GSK said it voluntarily initiated the recall of the 22 lots after it was discovered that the API for the product was potentially contaminated with penicillin and foreign substances during manufacturing process.

A GSK spokesperson said in an emailed statement that during a routine FDA inspection of GSK's Worthing Primary manufacturing site, where the Bactroban active pharmaceutical ingredient is produced, it discovered that certain batches could have been contaminated. GSK decided to voluntarily recall all potentially impacted batches of Bactroban Ointment, Bactroban Cream and Bactroban Nasal Ointment. The folks at the site investigated the cause and are now taking "corrective and preventative actions."

GSK spokeswoman Camilla Dormer said Thursday that "no contamination or contaminated product had been identified."  The company also said no adverse reactions have been reported, and patients should not stop using any of the products without consulting their physician. 

It has been a difficult couple of years for GlaxoSmithKline, with extensive recalls in the U.S. In April, the company recalled 1.7 million doses of its quadrivalent flu vaccine that were manufactured at a plant in Canada that ran into a series of manufacturing issues last year including an FDA warning letter. Last month, the drugmaker had to recall nearly 4 million tubes of toothpaste that might have been contaminated with wood particles. But in that case, the product was not manufactured by GSK itself but by Oratech, a Utah-based contractor. Last year the drugmaker recalled Paxil patches after being lambasted by the FDA in a warning letter for releasing potentially contaminated products from a plant in Ireland and not even bothering to tell customers about the potential for problems.