India is planning to spend about INR17.5 billion ($270 million) to make sure every state has a drug testing laboratory as part of an effort to improve manufacturing quality.
Novartis has issued a voluntary recall of more than 10,000 bottles of a drug used to treat attention deficit hyperactivity disorder (ADHD) that were manufactured at a plant in Georgia.
Continued problems at Sun Pharmaceutical's Halol facility in India sparked the U.S. Food and Drug Administration to pull its approval for the company's research arm to launch a drug for seizures.
Iodine is routinely used on patients ahead of operations to help protect against bacteria contamination. But what if the iodine itself is contaminated with a toxic chemical? That is the issue facing 3M, which is recalling thousands of cases of surgical applicators.
Two years ago, Sun Pharma was before the U.S. Supreme Court defending a label for one of its generic drugs against claims that it didn't adequately warn against risks. Now the labels on some of its drugs are creating another kind of problem, leading to a recall of more than 216,000 bottles of drugs.
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.