SCA Pharmaceuticals LLC, is recalling nearly a dozen types of injectable drugs including several opioid painkillers because they may be contaminated with bacteria that could cause life-threatening infections. To date, the drug company has not received any customer complaints or reports of adverse events related to this issue.
The recall affects more than 4,000 units of injectable drugs including the skeletal muscle relaxants succinylcholine and rocuronium, labor inducer oxytocin, hypotension drug phenylephrine, hypocalcemia treatment calcium gluconate, and the opioids fentanyl, fentanyl plus bupivacaine, morphine, hydromorophone, and hydromorophone plus bupivacaine.
Administration of a drug product intended to be sterile that may contain microbial contamination has the potential to cause serious adverse events, some of which could be deadly, the company said in a recall notice.
Affected products were distributed to hospitals nationwide. A list of the recalled products, their indicated use, and package type are identified in the company’s Recall Notice. Affected products can be identified by the attached labels.
SCA Pharmaceuticals is notifying hospitals of this recall and is arranging for return and replacement of all recalled products. Consumers who have experienced health problems after receiving any drug products affected by this recall should contact their doctors. Any adverse events should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Recall Notice