Another Hospira recall: of an overfilled, potentially fatal, pain drug

Houston drug injury attorneys on the latest Hospira drug recall. Hospira is possibly the world’s leading maker of generic injectable drugs and infusion technologies. Headquartered in Illinois, the company is such a behemoth in the field that the U.S. FDA generally won’t even let it issue large recalls, because the recalls would lead to widespread shortages of necessary and affordable drugs.

So Hospira also has no grand incentive to correct its quality control and manufacturing issues. Hospira will recall isolated lots occasionally in which particular issues have been confirmed, but generally does not recall related lots in which the same issue might appear.

For instance, earlier this year, our Houston drug injury attorneys reported on the Hospira recall of 19 lots of 4 cancer medications, including carboplatin, because of the presence of glass particles at the neck of medication vials. The glass particles could be injected with the drug and cause injury. Hospira blamed the problem on its supplier of glass vials.

In spring, Hospira had recalled some single lots of overfilled injection cartridges of its pain medications containing morphine and hydromorphine. In June, Hospira admitted that the problem with the overfilled injection cartridges was much more extensive than it originally indicated. The company tied the problem to as many as 15 different Carpuject products in up to 280 lots.

But the FDA would not allow a recall because of the danger of immediate drug shortages, and so Hospira simply notified healthcare providers to assume the additional burden of checking its Carpuject cartridges for overfilling and making manual adjustments if necessary. Our Houston drug injury attorneys worry because, in effect, if Hospira experiences a problem with a product, it could effectively shift the burden of dealing with that problem to someone else. Sweet deal if you can get it.

At least one lawsuit sought to hold Hospira accountable for its quality control issues in manufacturing. The lawsuit claimed that shortage of a Hospira drug caused a woman’s blindness. Hospira, not unexpectedly, slipped out from under liability in that lawsuit. But the company and its poor quality practices have been named in a U.S. House of Representatives committee report as key reasons behind U.S. drug shortages.

The Hospira drug recall this time relates to overfilled Carpuject cartridges of hydromorphone. Hydromorphone is a generic version of the more expensive branded opioid pain medications Palladone and Dilaudid. While the FDA wouldn’t approve a complete recall of the Carpuject hydromorphone, it consented to Hospira’s recall of the single lot in which a user found an overfilled cartridge due to the potentially deadly consequences of overdosage.

Our Houston drug injury attorneys point out that an overdose of an opioid pain medication like hydromorphone can produce lethal reactions that include slowed or suspended breathing (respiratory depression), low blood pressure, reduced heart rate, and potential circulatory collapse.

The recalled Hospira Carpuject product is one lot of Hydromorphone Injection, USP, 2 mg/mL (C-II), 1 mL fill in 2.5 mL, Carpuject™, NDC 0409-1312-30. The product affected by the recall consists of a pre-filled glass cartridge for use with the Carpuject Syringe system. The affected lot number is 12720LL. The expiration date is December 1, 2013. The affected lot was distributed from March through May 2012.

Hospira says that the company has not received any reports of adverse health events from the overfilled cartridges. And that it has concluded an investigation into the root cause of the problem and has taken measures to prevent another occurrence of the dangerous safety issue.

The company has been investing considerable time and effort trying to upgrade its manufacturing plants in Austin, TX, Clayton, NC, and Rocky Mount, NC since receiving warning letters from the FDA regarding manufacturing safety issues at the plants. Hospira hired consultants and new management teams to oversee quality and manufacturing. But our Houston drug injury attorneys emphasize that the plants’ quality control and dangerous safety issues have not yet been resolved.

Hospira has advised users to stop using any product affected by the Hospira drug recall. The company has stated that replacement medication is available from other lots.

But quality control at the world’s largest maker of generic drugs remains a concern. The potential consequences of the defect in this lot of recalled Carpuject Hydromorphone product, as well as in previously recalled lots of Hospira’s cancer drugs, could prove deadly.

If you or a loved one suffer adverse health consequences from a defective drug product, you will need aggressive and knowledgeable legal help to obtain the full financial recovery you deserve after your needless injury. As Hospira’s win in the lawsuit claim concerning blindness from a drug shortage indicates, such large, well-financed manufacturers are adept at dodging legal liability. Their highly trained and well-paid defense teams can make short work of individual claimants who don’t realize what they’re up against.

Get the experienced legal help you need after suffering adverse health consequences for a drug maker’s quality control issues. Contact the adept Houston drug injury attorneys at Denena & Points for a free and confidential legal consultation. And get started down your road to a successful financial recovery.