Upsher-Smith had to quit shipping fluoxymesterone tablets last fall when its supplier quit making the API for Androxy. The problem was that Upsher-Smith is the only supplier in the U.S. for the drug, which is used to treat breast cancer in women and low testosterone in men. Now Upsher-Smith says Androxy is back.
With the completion of a spinoff July 1, Baxter International let go of most of its drug operations go with Baxalta while keeping its dialysis equipment, IV pumps and solutions, and injectable drugs and intravenous nutrition. In that category falls saline solution, and Baxter is again having to recall some of that; in this case, two lots because a customer discovered particulate that turned out to be insects.
For the third time this year, a drugmaker is having to recall birth control pills in North America. This time, it is Actavis, which is voluntarily recalling more than half a million boxes of contraceptives because of packaging problems.
The HIV-oriented joint venture of Pfizer, GlaxoSmithKline and Japan's Shionogi is turning to a Chinese manufacturer for a cheap supply of dolutegravir, the active ingredient in its Tivicay. The deal is seen as a way to cut the cost in China and some other developing countries of the JV's newest HIV fighter.
This year the FDA gave drugmakers, wholesalers and logistics companies an extra four months to get on board with new regulations requiring them to be able to track lots of prescription drug products all along the chain of custody. Now pharmacy groups are asking if they could catch a similar break.
China's Zhuhai United Laboratories bills itself as the world's largest manufacturer of the API for the antibiotic amoxicillin. But the sterile manufacturing for some of its amoxicillin products has been called into question by inspectors in Europe, which is banning the sterile drugs for now, except in limited cases.
Three members of a gang that for years made South Florida one of the most dangerous spots for cargo theft in the country are going to federal prison for their part in a scheme to steal and resell $2.2 million worth of the cold medicine Mucinex and $500,000 worth of baby formula off tractor-trailers.
Sterile injectable drugs are a growth area, but they are notoriously tricky to manufacture. Mylan has found that out the hard way and is having to expand a recall of cancer drugs that it began in April because they may contain particulate. Some of the drugs were manufactured for Pfizer.
Hospira recalled more than 60 lots of the pain reliever ketorolac tromethamine injection in January because of the potential for crystals in the 18 million vials that had been shipped in the U.S. and Singapore.
For the second time in 8 days, law enforcement authorities have charged people with buying drugs illegally and reintroducing them into the legitimate supply chain.