The problems with overfilled Hospira Carpuject syringes is far more extensive than first suspected, but instead of ordering a recall, which would create some immediate shortages, the FDA is leaning on health professionals to make sure the drugs are administered correctly.
Hospira ($HSP) alerted the FDA in April and May of overfilled cartridges containing morphine and hydromorphine after receiving complaints from users. That led the company to investigate. The probe led to the determination that as many as 280 lots of 15 different Carpuject products might have been overfilled. The FDA says that some of them may contain more than twice the labeled dosage. The products 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.
In an emailed statement to FiercePharmaManufacturing, Hospira spokesman Daniel Rosenberg said "the potential for overfill occurrence is low, but medication overfill has been reported." He said the company has worked closely with the FDA to determine the appropriate steps.
Since the number of cartridges that may be overfilled "appears to be low" and the risk of shortages if all the lots are pulled is significant--and since healthcare professionals have the expertise to check--the FDA decided on the alert instead of a recall, the agency says.
The recalls and alert come even as Hospira has been putting extra attention to quality control after the company had to make improvements at three plants to address manufacturing issues outlined in an FDA warning letter.
- read the FDA alert