The Cantrell Drug Company of Little Rock, Arkansas is voluntarily recalling certain unexpired sterile drug products due to lack of sterility assurance.
The recalled products, distributed nationwide to health care facilities from May 25 to October 31, 2016, include a variety of drugs, but among them are several drugs used frequently in workers’ compensation, such as:
- Fentanyl citrate, an opioid used to treat severe pain
- Hydromorphone hydrochloride, an opioid indicated to treat moderate to severe pain
- Lidocaine hydrochloride, an analgesic for mild pain
- Morphine sulfate, an opioid used to treat moderate to severe pain
Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening. Cantrell has not received any reports of adverse events, but is issuing this recall out of an abundance of caution following a recent inspection of the company’s facility.
For more information, such as the doses affected, NDCs, and lot numbers for the recalled products, read the FDA’s recall announcement.