Topic:

QA/QC

Latest Headlines

Latest Headlines

Europe bans Chinese API maker over contamination issues

The European Directorate for the Quality of Medicines has banned products from a Chinese maker of iodine after an inspection at its plant by French inspectors turned up contamination issues in its manufacturing processes, issues with its purified water system and a piece of testing equipment that may have been put in the facility just for show.

Manufacturing mess at J&J consumer plant results in guilty plea, $20M fine

The McNeil Consumer Healthcare plant in Pennsylvania where a laissez-faire attitude about quality led Johnson & Johnson into a regulatory quagmire has now led the drugmaker to plead guilty to a federal misdemeanor charge and fork over $25 million.

Hospira issues another recall even as Pfizer announces buyout deal

Recalls from injectable drug specialist Hospira are a regular occurrence, but the one announced by the FDA today comes at a particularly inopportune time. The FDA posted the recall in its weekly Enforcement Report on the same day that Pfizer announced it was buying Hospira in a $17 billion deal.

Hospira recalls more saline after human hair found in a bag

A loose hair has contributed to the nationwide shortage of saline solution, as Hospira recalls another lot of the commonly used product.

UPDATED: Actavis recalling 2,000 bottles generic seizure drug

Actavis has another drug recall to deal with, this one involving nearly 65,000 bottles of the generic version of the seizure drug Neurontin that it manufactures at a plant in India. The voluntary recall follows one in November of a drug that was key to its acquisition last year of Forest Pharmaceuticals.

Valeant says inhaled drug used on infants may be contaminated

Valeant Pharmaceuticals has started the new year with a product recall. This time the drugmaker is recalling an inhaled med that can be used to treat hospitalized infants, one which it says is suspected of having microbial contamination.

India's Zydus Cadila finds blood pressure med has embedded brown spots

The U.S. arm of India's Zydus Cadila has initiated its second recall in the U.S. in the last 7 months, this time because tablets of a drug for high blood pressure were found to have brown spots.

Some Aurobindo epilepsy capsules found empty, prompting recall

India's Aurobindo has recalled a lot of an epilepsy drug because some of the capsules contain no drug at all.

Doc coughs up $2M for using unapproved Avastin on his cancer patients

A U.S. oncologist who thought he was getting a great deal on drugs that were almost the same thing as Avastin has found they will cost him an extra $2 million and a federal misdemeanor conviction.

Valeant recalls 205,000 bottles of blood pressure med

Trying hard to fight off a hostile takeover by Canada's Valeant, Botox maker Allergan has sent out press releases every time it stumbles onto something that appears to besmirch its pursuer. New fodder is in this week's FDA Enforcement Report. Valeant is recalling a couple hundred thousand bottles and tubes of products.