Eight months after domestic drug major Dr Reddy’s announced a voluntary recall of a single lot of its cholesterol lowering drug simvastatin (80 mg) from the US market, the company has recalled more lots of the same drug of different strengths.
Over 60,000 bottles of 10 mg and 40 mg of simvastatin will be recalled from the market, the company informed the US Food and Drugs Administration (USFDA).
The USFDA, in its weekly-enforcement report on August 10, stated that “certain batches of simvastatin tablets are being recalled due to complaints from consumers who found the tablets smelled musty or moldy”. It also stated that Dr Reddy’s investigation pointed to the presence of the same contaminants that were found earlier. In December 2010, Dr Reddy’s had recalled 25,896 bottles due to chemical contaminations.
A Dr Reddy’s spokesperson said the company has already implemented a corrective action upon identification of the root cause. “Dr Reddy's had initiated the initial voluntary recall on December 13, 2010, and a subsequent voluntary recall on June 6 (draft recall notice was sent to the FDA on May 25). The FDA has not ordered a fresh recall related to this matter," the spokesperson said in an email response.
The recall comes under the Class II category, which means the probability of serious adverse health consequences is remote. At most, use of or exposure to such a product may cause temporary or medically reversible adverse health consequences.
Industry analysts said the development may not have any major revenue implications for Dr Reddy's but assumes significance in the backdrop of a new risk-based investigation model adopted by the USFDA.
USFDA has already established an Indian presence and routinely inspects domestic manufacturing facilities that export medicines to the US.
India’s largest drug company by sales, Ranbaxy, is yet to get USFDA nod for two of its domestic manufacturing plants after the regulator found fault with those facilities two years ago.
Recently, Dr Reddy's Mexican drug manufacturing plant had come under USFDA scanner.