With its recall this week of four cancer drugs and other meds here and around the world, generic sterile injectables manufacturer Hospira ($HSP) made it four months in a row that it has had to warn the healthcare industry of new issues with its products. This time it pins the blame on a glass supplier.
In a joint release with the FDA, the company says in the U.S. it is recalling 19 lots of carboplatin, cytarabine, paclitaxel and methotrexate, shipped between September and April. The notice says vials have been found with "visible particles embedded in the glass located at the neck of the vial.''
Hospira spokesman Daniel Rosenberg tells FiercePharmaManufacturing via email: "Hospira has not received any reports of adverse events related to these lots. The root cause is a supplier glass defect, and we have taken corrective action to prevent this from occurring again. For U.S. customers, replacement product from other lots is available and no drug shortages are expected as a result of this recall."
The company also is recalling drugs from countries that range from Canada, to Norway, to Australia to Vietnam. Those recalls do not include cytarabine, but do include some drugs not being recalled here--heparin, desferrioxamine, oxaliplatin, fluorouracil and epirubicin. Rosenberg said there may be some temporary shortages of some drugs in some countries but "In most cases we will have replacement stock available, and we don't anticipate major disruptions for the majority of our overseas customers."
Shortages due to drugmakers' manufacturing problems have been a hot issue the last two years and Hospira has found itself in the middle of it. It is one of four genericsmakers named in a House committee report last month and tied to serious drug shortages in the U.S. because of FDA action requiring each to fix quality issues in production processes. It has also found itself on the vanguard of a new legal strategy, patients or their families suing drugmakers claiming that a shortage of the medications they were getting has worsened their conditions, even led to death. When a Tampa, FL, woman found she couldn't get Hospira's Aquasol A, she sued, claiming that she is now blind in one eye because she relied on the drug for a vitamin A deficiency. A federal judge ruled against her, saying Hospira was not responsible for keeping a sufficient backlog of the drug to avoid a shortage when production was halted.
Hospira has spent months upgrading its plants in Austin, TX, and Clayton and Rocky Mount, NC, after the FDA issued warning letters about shortcomings. The Rocky Mount plant closed in December for maintenance then resumed production in January after the company brought in consultants and made upgrades to get a handle on FDA concerns.
But problems have persisted. In April and May, Hospira recalled single lots of overfilled injection cartridges containing morphine and hydromorphine. In June, however, it acknowledged that the problem was far more extensive than first believed and could affect as many as 280 lots of 15 different Carpuject products. But instead of yanking the products out of the supply chain, which the FDA said would lead to immediate shortages of some products, healthcare providers were alerted that they needed to visually inspect the products and adjust doses if cartridges were overfilled.
- here is the FDA press release
- and a Reuters story
House report blames FDA actions for drug shortages
Hospira shortage can't be blamed for woman's blindness
Hospira overfills far greater than first thought
Hospira earnings decline tied to ongoing remediation