|Courtesy of Parhamr, CC public domain|
Pfizer, which had to recall an injectable drug last month, is now recalling three lots of an antidepressant after a pharmacist discovered a capsule of one of Pfizer's heart pills in an Effexor XR bottle, a potentially deadly combo.
The New York-based Pfizer ($PFE) said it had voluntarily recalled two lots of different quantities of Effexor XR and one lot of its Greenstone-branded venlafaxine, its branded generic version. The drugmaker said the risk that any other bottles might be affected is slim, but it decided to recall the three lots as a precaution. All three were run on the same packaging line. Pfizer told Fox News that the three lots total about 104,450 bottles, and about 65,800 have already hit pharmacies. The heart drug found in an Effexor XR bottle was Tikosyn, a med used to treat irregular heartbeats. Patients prescribed Effexor XR who took Tikosyn by mistake could potentially have a fatal reaction, the drugmaker cautioned.
In February, Mylan ($MYL) recalled 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 $1.75 billion acquisition of India's Agila Specialties. Pittsburgh-based Mylan said that the cartons and the vials may also be missing lot numbers and expiry dates or they may be illegible on the vials.
There has been a series of recalls in recent weeks including from the problem-plagued Ranbaxy Laboratories. The FDA said in its weekly enforcement report that Ranbaxy is voluntarily recalling nearly 65,000 bottles of atorvastatin calcium in the U.S. after a pharmacist reported finding a 20-milligram tablet in a sealed bottle marked for 10-milligram pills. The company had to recall 41 lots of the product in 2012 after glass particles were suspected of having ended up in some bottles. The same FDA report that mentioned the Ranbaxy recall also listed a recall from Gilead Sciences ($GILD) and Bristol-Myers Squibb ($BMY) of about 39,000 bottles of their HIV medication Atripla in which red silicone rubber was found. The FDA report said it was manufactured in Ireland, while an investor report said "management" indicated it was made by a contractor in China. In addition to those recalls, last week Baxter International ($BAX) 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.
In recent years, the FDA has been building up its efforts to face down quality problems that put patients and the supply chain at risk. 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 even suggested giving letter grades to manufacturing plants and letting the marketplace help weed out bad players.