Topic:

QA/QC

Latest Headlines

Latest Headlines

Another drug company blames freezing during delivery for product problems

Bausch & Lomb recalled nearly 900,000 tubes of eye ointment last month, saying that freezing temperatures during delivery appeared to have caused the grit that some customers were complaining about. Now a Colorado biotech is also claiming to have fallen victim to that kind of supply chain issue, although its announcement raised eyebrows among observers.

Amgen recalls Aranesp syringes contaminated with polyester

Amgen is recalling 9 lots of an anemia drug from 14 countries outside of the U.S. after syringes were found to have cellulose and polyester particles in them. The recall comes at a tough time for Amgen's manufacturing operations, which were just targeted for big cuts to prepare the company for future competition to a key product.

Baxter recalls another lot of saline solution as shortage persists

Baxter International, which has been scrambling to get added supplies of saline to the market in the midst of a national shortage, is recalling one lot of large-volume bags in the U.S. because of contamination.

Cubist issues third recall in 12 months after another CMO quality failing

Cubist is going through a bad patch with outsourced production. The problems began in August 2013, when CMO quality failings prompted Cubist to recall four lots of its injectable antibiotic Cubicin. Having summoned back another lot in April, Cubist has now issued a much larger recall, with about 100 lots affected.

Ranbaxy shakes up its executive ranks for manufacturing oversight

After years of manufacturing lapses left it with four of its 5 FDA-approved plants banned, a consent decree and now a deal to be sold, Ranbaxy Laboratories has cleaned house in its quality oversight ranks.

India faces higher QC costs as Shasun shows value of compliance

Rising recognition of FDA scrutiny and the cost of quality failings have prompted Indian drugmakers to double spending on compliance over the past 5 years, credit rating agency Crisil reports. And Indian investors are increasingly conscious of the value of such investments, with Shasun Pharma seeing its stock jump 16% this week after it got through an FDA inspection with just a Form 483.

Pfizer recalling 221,000 bottles of Pristiq as tablet mix-up again trips it up

For the second time in recent months, Pfizer is having to recall hundreds of thousands of bottles of a drug when one was found to contain the wrong tablet. Pfizer says a single 100 mg tablet of Pristiq Extended Release was found in a 50 mg bottle but the drugmaker is taking no chances and is recalling four lots of the the antidepressant drug.

Bristol-Myers recalls 6 lots of injected Coumadin

Bristol-Myers Squibb in April quit making injected Coumadin, the form used in the rare cases when patients can't take the oral formulation. But there is still product in the market and and the company is having to recall some of it.

India's IPA hires consulting firm to help it overcome bad publicity

Thinking it needs to change the spin on the story, an industry group in India has hired a Washington, D.C., consulting firm which is launching a campaign it hopes can do that.

Supplier of unprotected foreign-made cancer drugs gets 15-month prison sentence

Federal authorities have torn down another pillar in a wide-ranging business that sourced foreign-made cancer and other drugs and sold them to U.S. doctors at a discount. Some of the meds were cold-chain drugs that were sometimes left unrefrigerated in Pakistan.