An investigation into user complaints of overfilled Carpuject syringes led Hospira ($HSP) to realize manufacturing problems with overfills were far more extensive than it first believed.
The company, which alerted the FDA in April and May of overfilled cartridges containing morphine and hydromorphine, nows says the problem could affect as many as 280 lots of 15 different Carpuject products. In an emailed statement to FiercePharmaManufacturing, Hospira spokesman Daniel Rosenberg said "the potential for an overfill occurrence is low, but medication overfill has been reported."
Rosenberg said the company has worked closely with the FDA to determine the appropriate steps. The agency in an alert says that some of the syringes may contain more than twice the labeled dosage. The affected treatments include everything from the morphine products to naloxone hydrochloride, which reverses the effects of opioids, to heparin and heparin lock, according to a list on the FDA website. But because a recall could cause immediate shortages of some drugs, the FDA instead is asking health professionals to visually check the potentially affected syringes before use to make sure the drugs are administered correctly.
The company has announced a series of manufacturing and quality-control management changes and has declared its intent to get on top of problems since the current series of manufacturing issues began last year. Rosenberg would not say which plant was responsible for the current problem, but told in-PharmaTechnologist it was not Rocky Mount, NC, one of it plants that is addressing issues in an FDA warning letter. The company has also been working through manufacturing issues raised by the FDA at plants in Austin, TX, and Clayton, NC. Earlier this month, it disclosed that a manufacturing glitch led it to a temporary production halt on its propofol line in Clayton, disrupting supplies of the sedative.
- read the FDA alert
- check out the in-PharmaTechnologist piece