Topic:

QA/QC

Latest Headlines

Latest Headlines

Baxter issues recall, this time because antibacterial gets mixed in wrong carton

Baxter International is again recalling a sodium chloride product, but this time, instead of particulate contamination, it is because another product was mistakenly mixed in the shipment.

Hospira again reports a human hair discovered in a product

A loose hair has again tripped up Hospira, which is voluntarily recalling one lot of heparin as a result.

Apotex recalls Paxil tainted at GSK plant

Apotex, the Canadian generics maker that has had years of regulatory run-ins with the FDA, is recalling thousands of bottles of generic Paxil. This time regulators can't point fingers at Apotex. The drugs were manufactured by GlaxoSmithKline and are part of a larger recall for which the FDA spanked GSK.

FDA fight with compounder tests its patience and its limits

For nearly two years, the FDA and a Texas compounder have been sparring over whether its products are safe and whether it will bend to the pressure the agency is exerting. The FDA sent a warning on Tuesday saying that the company cannot affirm its products are safe and that providers were taking a chance by using them.

Perrigo recalls 367,000 tubes of nicotine lozenges

Smokers often turn to over-the-counter nicotine lozenges to cut their urges when they are trying to quit smoking. It turns out that products made by Perrigo and sold through a whole host of retailers like Wal-Mart and CVS might not work that well.

Boehringer Ingelheim recalls cancer drug made at ill-fated Bedford plant

Boehringer Ingelheim is still recalling products that were made at its Ben Venue plant in Bedford, OH, even though it no longer owns the massive site.

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.