Another drugmaker is having to recall metoprolol succinate extended release tablets, a generic for AstraZeneca hypertension drug Toprol XL. This time it is Mylan and the recall is for nearly 16,000 bottles of the beta blocker.
Johnson & Johnson's Janssen unit is recalling 13,500 bottles of its top-selling anticoagulant Xarelto because of microbial contamination.
The Office of Pharmaceutical Quality will finally open Jan. 1, and the FDA's Janet Woodcock will serve as its first acting director.
The U.S. government invested $440 million in three vaccine plants in the U.S. in 2012 with the proviso that if something like a pandemic occurred, it could call on them to produce drugs that it required. With Ebola spreading, those calls have now been made.
More than three dozen drugs and APIs that were originally banned by health regulators in Canada will be allowed into the country because they are medically necessary.
Puerto Rico, which has seen a number of plant closings recently, is facing another. Eli Lilly said it will close a facility in Guayama next year and put it up for sale.
U.S. drugmakers are not the only ones building plants in Ireland to take advantage of the lower taxes and incentives afforded there. Italian specialty drugmaker Cosmo says that is what it intends to do.
The FDA, which has been corralling human drug compounders, is also keeping track of some focused on animal drugs.
In May, the FDA sent U.S. marshals into a warehouse to seize $11 million worth of drugs, everything from ear drops to urea cream, from an Indian company that the agency said were unapproved. Now the company is going to have to destroy them all while the FDA watches.
Abbott Laboratories, which has made a large bet on its global nutrition business, is in the final throw of a manufacturing triple play. The Chicago-area company this week opened a nutrition products plant in India after opening plants in the U.S. and China several months ago.
Hospira is recalling "certain lots of several products in its LifeCare line of flexible intravenous solutions due to the potential for leakage." But the description does not get to the depth and breadth of the recall, which is for 54 lots of nearly a dozen products. That includes two dozen lots of saline solution in the 1000-mL size, an essential hospital product that has been in short supply for months.
The FDA has taken steps against a Chinese heparin maker it says is using potentially tainted raw supplies and which refused to let inspectors get a good look at its plants or records so that it could find out for sure.
Some Indian companies that had put off production of HIV/AIDS meds while they waited for the government to sign contracts are now having to seriously ramp up because of shortages of some meds, Reuters reports.
Construction of a $150 million plant that Novartis is building near St. Petersburg in Russia has been halted because of "technical reasons," just short of completion.
In March, Sun Pharmaceutical recalled more than 2,500 bottles of its diabetes treatment metformin HCl after a customer reported finding an epilepsy pill in one. The company said it was investigating the issue, but apparently not to the satisfaction of the FDA.
While GlaxoSmithKline's new drugs Anoro and Breo have yet to take flight like the company had hoped, the drugmaker has been expanding the North Carolina plant where it makes them and other respiratory drugs, expecting that they will.
With Ebola rampaging through West Africa and now having reached the U.S., U.S. officials and the maker of an experimental Ebola drug manufactured from cells grown in tobacco leaves, ZMapp, want to expand the drug's current production while also seeing if traditional mammalian-cell methods might be used to quickly scale up production of the drug.
With four of its pharmaceutical plants in India banned from shipping products to the U.S., Ranbaxy Laboratories' U.S. operations have become essential to keeping product flowing into its biggest market. But with Ranbaxy's merger with Sun Pharmaceuticals getting close to closure, many of Ranbaxy's top U.S. execs are bailing out, putting some strain on its U.S. efforts.
CorePharma last year secured an FDA closeout letter for resolving the agency's concerns over its plant in New Jersey. Now that Impax Laboratories is picking up CorePharma and some sister businesses in a $700 million deal, CorePharma can share with Impax just how it managed to get that done.
Not all drug recalls track back to quality issues during manufacturing. A glitch in the supply chain can also come into play, and that is what happened with a lot of vancomycin hydrochloride injection being recalled by Hospira.