India's Ranbaxy Laboratories has issued another recall for its generic Lipitor, again drawing attention to its serious manufacturing and drug-testing lapses. But a series of product recalls in recent weeks illustrate that the kind of quality lapses the FDA has been harping on, and which it says often lead to drug shortages, have come from plants around the world and companies as varied as Pfizer ($PFE), Mylan ($MYL) and Gilead Sciences ($GILD).
The FDA said in its weekly enforcement report that Ranbaxy is voluntarily recalling nearly 65,000 bottles of atorvastatin calcium in the U.S. after a pharmacist reported finding a 20-milligram tablet in a sealed bottle marked for 10-milligram pills. The company had to recall 41 lots of the product in 2012 after glass particles were suspected of having ended up in some bottles. The plant where Ranbaxy manufactured its copy-cat version of Lipitor for the U.S. was banned in September from shipping any more product here after the FDA cited it for a number of problems. Then in January, the FDA banned another Ranbaxy plant, its fourth in 5 years, drawing a focus on the missteps that have plagued it and other Indian makers of generic drugs.
But Indian drugmakers are certainly not alone in having to recall drugs because of manufacturing issues. Baxter International ($BAX) last week recalled one lot of a peritoneal solution used on dialysis patients because it was contaminated with mold. The company acknowledged it had received reports of adverse reactions. Within days Pfizer recalled three lots, 104,450 bottles, of its antidepressant Effexor XR after a pharmacist discovered a capsule of one of Pfizer's Tikosyn heart pills in an Effexor XR bottle, a potentially fatal combo. The company said risks of other bottles being affected were low but recalled the products anyway.
But there were more. The same FDA report that mentioned the Ranbaxy recall also listed a recall from Gilead Sciences and Bristol-Myers Squibb ($BMY) of about 39,000 bottles of their HIV medication Atripla in which red silicone rubber was found. The FDA report said it was manufactured in Ireland, while an investor report said "management" indicated it was made by a contractor in China. Then there was the recall last month by Mylan of 10 lots of the injectable "hypnotic drug" etomidate in 2-, 10- and 20-mL doses because pieces of shredded labels were found in some vials. The drug was manufactured for Pfizer in a plant in Poland that Mylan recently acquired in its $1.75 billion acquisition of India's Agila Specialties.
In recent years, the FDA has been building up its efforts to spot, prevent or deal with lapses in quality manufacturing throughout the global supply chain. Problems with quality at manufacturing plants have been implicated in the majority of drug shortages as well as created suspicion among doctors that some generic drugs are ineffective. Last year the agency created the Office of Pharmaceutical Quality within the Center for Drug Evaluation and Research (CDER). Janet Woodcock, CDER director, has suggested giving letter grades to manufacturing plants and letting the marketplace help weed out bad players. Last month she said in one new effort that the new office is talking with industry to develop data that could be an early indicator of when plants are deviating from standards and need inspection, Bloomberg reported. "We want to use leading indicators," she told the news service. "These people aren't in trouble yet but they could be."