Sagent Pharmaceuticals, which relies primarily on contract manufacturers, is recalling a paralyzing agent used in surgery that is manufactured at a plant in Turkey. The company said testing found a high level of impurities.
A warning letter has been issued to Contract Pharmaceutical Services of Australia, which does drug packaging at a plant in the Sydney suburb of New Ryde.
While Ranbaxy's cover-up of shoddy manufacturing eventually led to a guilty plea and a $500 million penalty in the U.S., there have never been any consequences in its home country of India. Recent public outrage has prompted a stir among government officials about the matter, but some in the public are taking matters into their own hands.
Manufacturing problems at Impax Laboratories' California plant first cost the company a drug approval, then a $186 million partnership with GlaxoSmithKline. Now, it is costing 110 workers their jobs.
Any drug manufacturer that fails to take instructions from FDA is inviting trouble, and that is what Novartis got by releasing products from a Sandoz Ebewe plant after the agency said they had been manufactured using unapproved inspection procedures.
Already facing a criminal probe in South Korea over problems with its Janssen over-the-counter plant there, as well as issues in India and Brazil, it is now recalling 32 million boxes of its Cilest birth control pills because of solubility issues.
Generic drugmaker Sandoz is recalling two lots of an injectable drug, making yet another manufacturing problem for its parent, Novartis.
The FDA cast a wider net this year as it sent inspectors into what it called 30 "high risk" compounding pharmacies, those that made sterile drugs that can easily be contaminated. The attack has had a pronounced effect on the number of recalls the agency has ordered.
The Indian drugmaker will pay the largest ever drug safety settlement for a generic manufacturer--$500 million--to put the case to rest.
It has been a particularly bad few days for Hospira, with both the company and the FDA alerting healthcare providers of problems with multiple lots of its drugs. That was in addition to an alert for one of its medical products.