GSK to expand recall of antibiotics made at Worthing API unit
The firm said it would expand the recall of Bactroban antibiotics made at the active pharmaceutical ingredient (API) manufacturing area of its facility in Worthing, UK in response to a warning letter published by the US regulator this week.
In the letter - which details incidences of penicillin cross contamination and microbial contamination observed during a visit in July 2015 – the Food and Drug Administration (FDA) says GSK must either decontaminate the plant or only use it for penicillin API production.
In a statement sent to us today GSK said: “Given the very specific nature of the Warning Letter GSK will now propose a Pharmacy Level (Level 2/Class2) recall from the US market of the small number of Bactroban batches remaining within shelf life.”
No active pharmaceutical ingredients (API) have been made at the facility since the FDA inspection according to GSK, which said it had undertaken “a detailed programme of work to address and correct the matters raised.”
Recall
The Bactroban recall began last August when GSK asked wholesalers to hand back ten lots of products made at the Worthing site between December 2014 and July 2015. The recall was expanded to include retailers a month later.
A spokeswoman confirmed the latest expansion, telling us the proposed level 2 recall in the US is “in addition to the measures taken last year.”
She added the aim “is to ensure any batches of Bactroban which remain in shelf life are removed from pharmacies in the US.”
GSK told us it “is taking the Warning Letter extremely seriously and it is now being reviewed to determine if further action is necessary” adding that it “will submit its response to the FDA Warning Letter on or before 25 July, 2016.”
The firm declined to comment when asked if it had transferred API production to another facility or used a contract manufacturing organisation (CMO) since closing the production unit.
