GSK Recalls More than 400,000 Tubes of Antibiotic

GlaxoSmithKline has issues a voluntary Class II recall of 421,513 tubes in various product forms for Bactroban (mupirocin calcium), an a topical antibacterial for treating skin infections. The recall was initiated on August 13, 2015 due to penicillin cross contamination and the presence of foreign substances. The products were contaminated with penicillin and foreign substances during the manufacturing process. The recall applies to the United States, including Puerto Rico. The recall was listed in the US Food and Drug Administration’s Weekly Enforcement Report of September 2, 2015.

A Class II recall is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

The recall applies to products manufactured by Glaxo Operations UK Ltd in Barnard Castle, UK for GlaxoSmithKline in Zebulon, North Carolina.

GSK issued a voluntary recall of the following: 88,489 tubes of Bactroban (mupirocin calcium) Nasal Ointment, 2% 1-g tube;19,520 tubes of Bactroban Ointment (mupirocin calcium), 2% 22-g tube; 28,480 tubes of 15-g and 12,234 tubes of 30-g of Bactroban Cream (mupirocin calcium), 2%; 166,070 tubes of 15-g tubes and 112,720 tubes of 30-g tubes of mupirocin calcium cream, 2%.

Source: FDA

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