According to India’s Economic Times the recall covers some 4,300 boxes of the drug and is being conducted as a precautionary measure under the US Food and Drug Administration’s (FDA) Class III procedure.
Ranbaxy confirmed the move in a statement to the Times of India, explaining that it “is conducting a voluntary recall of Sotret Isotretinoin Capsules, USP 40mg, which is limited to a single batch, currently available in US market."
The news follows just three months after Ranbaxy was forced to withdraw 1303 cartons of the same drug as a result of out of spec dissolution and stability test results.
Sotret (isotretinoin) was one of 30 banned by the FDA in 2008 after the discovery of good manufacturing practice (GMP) deviations at Ranbaxy’s manufacturing facility in Paonta Sahib, Himachal Pradesh.
But, while the FDA ban stopped the importation of isotretinoin, it did not prevent Ranbaxy from selling off existing stocks of the drug that were already in the US supply chain.
Prior to the FDA ruling isotretinoin was one of Ranbaxy’s top five sellers in the US, generating around $50m (€36m) in annual revenue, equivalent to one third of the country’s total acne treatment market.
Since the ban however, the product’s market share has fallen considerably and, according to comments made in July by HDFC Securities’ VP of research Ranjit Kapadia, now only generates $1m a year in the US.
Neither Ranbaxy, nor Japanese owner DaiiChi Sankyo, have commented further on the latest recall, although both will hope that it does not derail ongoing efforts to overturn the US import ban.