Dr. Reddy’s pulls hundreds of thousands of bottles of Lipitor generic over impurity fears
Dr. Reddy’s Laboratories is in the midst of a large recall of its generic version of Lipitor—and that’s not the only product it’s yanking from the U.S. market.
Dr. Reddy’s Princeton, New Jersey, outfit is pulling hundreds of thousands of bottles of the cholesterol drug atorvastatin calcium in the U.S. due to impurities that turned up in the product. The company is also recalling one batch of the hormone progesterone after stability testing revealed subpar dissolution.
The Class III recall of atorvastatin, a generic version of popular cholesterol med Lipitor, kicked off Feb. 19 and covers 10,440 90-count bottles and 224,710 500-count bottles, both of which contain 40-mg tablets of the drug, according to an FDA enforcement report.
Dr. Reddy’s did not immediately respond to a request for comment.
The generic Lipitor at the center of the recall was manufactured by Dr. Reddy’s in Srikakulam, India, and distributed across the U.S. The FDA report notes failed impurity and degradation specifications for the drug, with the presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities found.
The second ongoing pull, initiated Feb. 26, covers 16,449 100-count bottles of 200-mg progesterone capsules. The drug was made in France and distributed by Dr. Reddy’s New Jersey operation, the FDA’s enforcement report states. The Class II recall, which suggests use of the drug could lead to temporary or medically reversible health problems, covers products deployed throughout the U.S.
The recalls come a little over a year after Dr. Reddy’s was forced to pull a generic form of Sanofi’s Zantac. The Zantac supply halt came after the online pharmacy Valisure tipped off regulators to the presence of a likely carcinogen, N-Nitrosodimethylamine (NDMA), in the branded form of the popular heartburn med and generic ranitidine drugs. The tainted drug ingredients were found to have come from Dr. Reddy’s and another Indian supplier, Saraca.
Dr. Reddy’s was able to find a new way back into the heartburn market earlier this year. In February, it launched an orally disintegrating form of lansoprazole, a generic version of Takeda’s Prevacid SoluTab delayed-release product.