Teva Pharmaceutical Industries voluntarily recalled 8 lots of a cancer drug a couple of months ago after rubber particles were found in some containers. Now the generics maker says the problem is more widespread than it first thought and more units will need to be retrieved.
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.
The burden of recalling products manufactured at Wockhardt's two plants in India currently under FDA bans has fallen in part to American Health Packaging, a subsidiary of AmerisourceBergen, which has issued more than a dozen recalls of 6 products in different doses.
Mylan put the word out in April that healthcare providers that had any of the 10-mL prefilled syringes of calcium chloride infusion from 14 specific lots manufactured for Amneal needed to return them. In June it sent out a reminder of the recall. This week, Mylan again asked providers to check their storerooms and crash boxes after learning some of the syringes are still being used.
Orexigen and Contrave marketing partner Takeda have been feuding over how they will split the cost of a postmarketing study on the drug's cardio effects after the initial study had to be canceled because of a "data leak" by Orexigen's CEO. Now they have a new splitting issue to bicker about. Takeda is having to recall a lot of the obesity drug because tablets in a batch were coming apart.
Fresenius Kabi, which has faced any number of actions by the FDA over manufacturing issues, is now having to cough up a substantial amount of money in the U.K. Fresenius Kabi and a sister company have been penalized £550,000 after a court found that manufacturing lapses were tied to the death of a patient in a U.K. hospital.
India's Dr. Reddy's Laboratories is having to recall both an epilepsy drug and a combo cardiovascular drug all made in India. One, the FDA says, is too strong while the other is not strong enough. The recalls come even as the FDA has been paying special attention to generic equivalence after testing has found evidence that some generics are not measuring up.
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.
When any member of the European Union finds issue with a drugmaker, it is reported to a central database to alert other members that might also buy from that facility. Now Slovenia has raised red flags about an Indian drugmaker it says it discovered during an inspection is not meeting cGMP standards.
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.