According to an FDA enforcement report, the Indian drugmaker is voluntarily recalling nearly 65,000 bottles of atorvastatin calcium in the U.S. after a pharmacist reported finding a 20-milligram tablet in a sealed bottle marked for 10-milligram pills.
Sterile injectables maker Sagent Pharmaceuticals is recalling a product because of leaking bags. It is the second recall in about 9 months for the company, which relies mostly on contractors to manufacture its products.
Labeling problems can lead to a recall, particularly when a drug is missing its expiration date labels--or some of the paper label pieces end up in vials. That is the scenario Mylan faces in recalling products made by Agila Specialties, the injectable drug company it bought last year for $1.7 billion.
F. Michael Ball has spent many earnings calls talking almost entirely about the quality problems at the company's plants and its long-running efforts to get past them. Wednesday he spent very little, an indication, executives said, that four years of effort and more than $375 million in investments are paying off.
Japanese drugmaker Daiichi Sankyo, which owns controlling interest in the Indian generics company Ranbaxy Laboratories, is having to rethink its strategy now that Ranbaxy's key API plant has been banned from shipping to the U.S. and its analytics lab came in for harsh criticism from the FDA.
Manufacturing problems have created shortages of a variety of vaccines around the world. Now GlaxoSmithKline is warning doctors in Germany to expect a shortage of two chickenpox vaccines because of quality issues that forced it to stop production.
Former Fresenius employee Ronald Hillier has filed a state whistleblower lawsuit in Cook County in Chicago, alleging that when he pointed out issues that he believed could result in contaminated products, the company canned him.
Merck is recalling all of the lots of its cholesterol drug Lipruzet distributed since its approval in the U.S. last May, saying that packaging problems could affect its potency. It has warned the FDA that shortages are expected from the voluntary recall.
India's Wockhardt, facing a raft of regulatory issues from the U.S. and Europe, is beefing up its quality oversight with a new leader for its regulatory and compliance division.
The new law that defines and broadens the FDA's oversight over drug compounders relies on the so-called outsourcers volunteering for oversight. So the big question was how many of the 3,000 or so firms would sign up. The answer as of Friday was 11.