It is another day and so another recall for Hospira ($HSP), the generic injectable drug maker that continues to struggle with issues even as it is overhauling three plants and using a phalanx of consultants to bring standards up.
The issue this time is overfills of Carpuject cartridges of hydromorphone, a generic version of Palladone and Dilaudid. The company in May actually warned healthcare providers that some of the Carpujects could be overfilled but decided in conjunction with the FDA not to recall them out of concern that it would cause a shortage. But today's notice by the FDA says that after a user discovered a cartridge containing more than the prescribed 1 ML of the opioid, Hospira decided to voluntarily yank that lot "in consideration of the potential for safety issues if the product is administered to patients."
While there have been no reports of adverse events from the excessive doses, the FDA points out that "opioid pain medications such as hydromorphone have life-threatening consequences if overdosed."
Hospira has spent months upgrading its plants in Austin, TX, and Clayton and Rocky Mount, NC, after the FDA issued warning letters about manufacturing problems. The company has brought in consultants and hired new management in quality and manufacturing but has yet to get ahead of its issues. It has been named in a House committee report as one of the key factors in drug shortages in the U.S. and has had to defend itself against a lawsuit saying that the shortage of one drug led to a woman's blindness, litigation that it successfully dodged.
But the problems have persisted. In July, Hospira recalled in the U.S. 19 lots of carboplatin, cytarabine, paclitaxel and methotrexate, shipped between September and April because of visible glass particles in the vials, a problem it laid on its vial supplier. It also recalled some products from countries ranging from Norway to Vietnam.
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. 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.
- see the FDA recall notice
Related Articles:
Hospira blames supplier's bad vials for latest recall
Hospira overfills far greater than first thought
House report blames FDA actions for drug shortages
Hospira shortage can't be blamed for woman's blindness
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