Over 236,000 bottles of Dr. Reddy’s Laboratories’ generic version of the popular cholesterol drug Lipitor (atorvastatin) have been recalled in the US and Puerto Rico. While the majority of the recalled lots were classified as a Class III recall – indicating that the recalled drugs would be unlikely to cause harm to someone taking them – 18 lots failed tests of impurities/degradation specifications.
One of the recalled lots was pulled from the market due to the presence of a “defective tablet with an embedded foreign object” in one of the bottles. This lot represents nearly 6,400 bottles of the generic Lipitor.
Dr. Reddy’s has been cited for numerous manufacturing violations in recent years, not least of which was an FDA-issued warning letter from 2015 which found the Indian pharmaceutical company was manipulating quality data and allowing workers to handle drug products in a way that could allow them to become contaminated. The regulator also found that batches of pharmaceuticals would routinely fail purity tests, however those drugs were still exported to the US.
The current voluntary recall affects 20 mg, 40 mg and 80 mg bottles of atorvastatin, all of which were manufactured at the company’s plant in Srikakulam, India. This site is one of three pharmaceutical manufacturing faculties run by Dr. Reddy’s that were the subject of the 2015 warning letter.
More recently, the company received an Established Inspection Report from the FDA which detailed more negative observations at the Srikakulam manufacturing site and will require corrective actions to be taken. While Dr. Reddy’s is permitted to continue to distribute its pharmaceutical products to the US, the warning letter could impact the company’s ability to get future approvals.
The latest generic Lipitor recall follows a similar recall of over 80,000 bottles of atorvastatin in February of this year. The bottles were recalled over the same quality concerns, indicating Dr. Reddy’s Srikakulam plant has plagued with the same manufacturing issues for months.