The British arm of Ranbaxy Labs is in the process of recalling three drugs from the UK market. The drug firm has been asked by the UK drug regulator — Medicines and Healthcare products Regulatory Agency — to withdraw one batch each of antiviral drug Aciclovir, anti-fungal drug Fluconazole and analgesic Oldaram (Tramadol) from the market. The recall happened as the drugmaker violated stipulated safety warning requirements of the country. It goofed up while implementing the required changes to the patient information leaflets accompanying the concerned drugs and failed to include updated safety information on the leaflets, within the required timelines. Pharmacists in the country have been asked to quarantine all remaining stock of the above batches.
This is the second episode of recall that Ranbaxy is having to undertake this year and the fifth within last two years from the UK market. Only three months back, the firm had to recall skin infection drug, Isotretinoin, from the UK.
The recall itself would have an insignificant financial impact on the drugmaker, but several recalls in quick succession could be a source of huge embarrassment for the company as these events are closely tracked by drug regulators across countries.
The batches of three drugs that Ranbaxy has been asked to remove from the market were scheduled to expire between May 2013 and January 2014. The concerned set of drugs were manufactured between October 2010 to February 2011
A company spokesperson confirmed the recall to FE. “Ranbaxy UK has recalled one batch each of Aciclovir 200mg Tablets, Fluconazole 150mg Capsules and Oldaram (Tramadol) 150mg PR tablets in consultation and agreement as the Patient Information Leaflets in these batches had not been updated to include approved safety warnings. There are no product quality concerns,” the spokesperson said.
The recall is of class-2 type, which implies the company has to start acting in the following 48 hours. In the hierarchy of recalls, class 1 is of the severest form, in which the firm has to initiate action immediately while the class 4 is the least critical advising ‘caution in use’. In between, a class-3 type recall