Topic:

QA/QC

Latest Headlines

Latest Headlines

Hospira recalls solution marked as heparin

Hospira is voluntarily recalling 181,704 bags of magnesium sulfate in 5% dextrose injections because labels on the immediate container may have barcodes indicating that it is instead the blood thinner heparin.

Apotex recalling generic Zyprexa because the antipsychotic may be too weak

Canadian generics maker Apotex is recalling more than 35,000 bottles of generic Zyprexa, an antipsychotic, that were manufactured at a plant in Toronto that was recently nicked by the FDA for a number of issues.

Mylan recalls injected cancer meds made for Pfizer

Mylan may be fending off an unsolicited $40 billion buyout offer from competitor Teva even as it is being rebuffed for making its own $31 billion bid for Perrigo, but it still has to take care of business as usual. Right now that includes having to recall 8 lots of injectable cancer drugs, most of it manufactured for Pfizer, after particulate was discovered in vials.

J&J recalls contraceptives for subpotency

J&J's Janssen unit is recalling one lot of Ortho-Cept tablets because of the potential that the potency of the two active ingredients may not meet specifications, Health Canada reports.

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.