Hospira has issued another recall, at least its fourth this year, as it continues to struggle to meet FDA expectations at its key sterile injectables plant. The plant has been an ongoing source of disappointment for the company, even as problems there and at other plants have been a gift to competitors who are boosting sales of products that Hospira has had trouble getting to market.
Hospira ($HSP) said in an FDA MedWatch that copper particles were found in a 1000-mL flexible container of its 0.9% sodium chloride injection, a product used as a source of water and electrolytes. Tests found that the particles contained copper, zinc and lead. Hospira warned that the particles might clog small blood vessels or potentially cause copper toxicity. It said it is looking for the root cause of the copper contamination.
The company asked providers to quarantine any of a specific lot of the sodium chloride, which was distributed to pharmacies and distributors between January and March. That would have been during the time that FDA inspectors were crawling over Hospira's Rocky Mount, NC, plant during a re-inspection that the company had hoped would demonstrate it was making sufficient progress to further ramp up production. Instead, inspectors left behind a 21-page Form 483, detailing 20 places where manufacturing continued to fall short.
Hospira, the largest maker of generic sterile injectables in the U.S., has been wrestling with problems as inspections since 2010 have found a long list of problems at plants in Rocky Mount, as well as at facilities in Clayton, NC, and Austin, TX. Hospira has invested more than $375 million in upgrades and services, but over the course of the last year, the company has repeatedly had to recall products and adjust expectations for investors. It had three recalls of 5 products while inspectors were in the plant for the re-inspection.
The ongoing problems at Hospira and the sterile injectables plants of other manufacturers like Boehringer Ingelheim's Ben Venue Laboratories have attracted new players to a market once thought to have too little profit to be worth the trouble.The medical technology company Becton Dickinson ($BDX) just last week announced FDA approval for its first sterile injectable drug, the antihistamine diphenhydramine hydrochloride injection, USP, which it will manufacture at a new plant in Wilson, NC. The company plans to bring out 20 to 30 products over the next few years, including some that have been on shortage lists. By selling the drugs in its prefilled syringes, BD expects to get a premium for its products based on saving time and improving safety for health professionals.
- here's the recall notice
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Inspection report details ongoing problems at Hospira
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Injection point: BD, Teva, Hikma target sterile injectables