When French biotech TxCell shut down its pilot manufacturing facility in Besançon in June, it said it was a decision made with regulators but didn't lay out exactly what an inspection by France's ANSM had found. Now ANSM has filed its report, and it turns out that what it found was a lot of cases of mold contamination and a number of facility problems that probably contributed to it.
The FDA has issued warning letters blasting any number of Indian API and drugmakers for not carefully testing drugs or sometimes fabricating test results of batches of their products that they shipped to the U.S. Now the agency has sent a warning letter to an Indian contractor some companies rely on for product testing and analysis, noting repeat violations of GMP standards.
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.