The Daiichi Sankyo-owned drugmaker Ranbaxy Labs Ltd has run into another trouble in the US market with having to voluntarily recall two lots of antibiotics ?Amoxicillin and Clavulanate Potassium for Oral Suspension ?used for paediatric patients, to treat or prevent infections caused by bacteria.
According to the information on the USFDA website, the drug was manufactured in Ranbaxy?s Dewas plant in Madhya Pradesh, the same facility which was blacklisted by the US drug regulator for good manufacturing violations in September, 2008 and since then have not been supplying to the US market. According to a Ranbaxy spokesperson, the drug lots in question were about to expire in May this year.
Although only 36,000 units of drugs are being recalled at a retail level from Ranbaxy, which implies minimal impact in terms of revenue to the company, the nature of recall has been classified as class II type. A class II recall has been defined by USFDA as ?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?. It is the class I type which is the most severe kind of recall.
The market size of the US generic market for this drug is estimated to be less than $50 million. Ranbaxy got the USFDA approval to market the generic version of this drug in 2007, around the time when GSK?s original drug had a market size of over $130 million.
A Ranbaxy spokesperson confirmed the recall, ?Ranbaxy Pharmaceuticals Inc, Jacksonville, Florida is conducting a voluntary recall of Amoxicillin and Clavulanate Potassium for Oral Suspension, 400mg/57mg (base) per 5mL, which is limited to Lot No 1910779 and Lot No 1910782 with expiry of May 2010 that is currently available in the US market?. He added, ?While Ranbaxy tested the lots in question and found them to be within specification, based on a limited number of complaints from the US market that describe a change in colour of the product upon reconstitution, the company has decided to recall all of the lots in question as a matter of caution, given its commitment to the health and safety of patients. The recall is being carried out to the retail level and is being conducted with the full knowledge of the USFDA.?
Last July, Ranbaxy?s US-based subsidiary, had recalled capsules used in the treatment of acne (a type of skin disease) from the US market. Before that it recalled voluntarily all the lots of its antibiotic drug – Nitrofurantoin (Monohydrate/Macrocrystals) Capsules in May 2009.