BETHESDA, MD 23 May 2012—An overfill problem that recently prompted the recall of a single lot of hydromorphone injection has been determined to affect up to 280 lots of 15 injectable medications packaged in Hospira's Carpuject syringe system.
In some cases, the products may contain at least twice the labeled volume of medication, according to FDA.
The affected products include pain medications, heparin solutions, benzodiazepines, and other drugs. A full list (PDF) of the affected product lots along with photographs showing their intended fill volumes is available on Hospira's website.
FDA today asked pharmacists to check each item's fill volume before dispensing the affected products. The syringe cartridges should be checked again by a health care provider before the medications are administered to patients.
Cartridges that do not contain the labeled volume of medication should not be dispensed and should be returned to Hospira.
FDA stated that it is recommending these visual inspection procedures instead of recalling the medications because a recall would cause "an immediate shortage" of the affected products. The agency is evaluating whether other steps are necessary to resolve the problem.
According to FDA, the appropriate product fill volume for Carpuject cartridges with a 1.5 mL capacity is 1.0 mL. Carpuject cartridges with a capacity of 2.5 mL may contain 0.5, 1.0, or 2.0 mL of solution, depending on the product. The fill volume for 5-mL capacity cartridges is 3.0, 4.0, or 5 mL.