Cantrell Drug Company issues voluntary nationwide recall of all sterile drug products due to lack of sterility assurance.
Cantrell Drug Company is voluntarily recalling all lots of unexpired sterile drug products to the hospital and user level due to lack of sterility assurance. The recalled products were distributed to health care facilities nationwide, except to the states of Connecticut, Hawaii, South Carolina and Vermont. To date, Cantrell has not received any reports of adverse events.
The affected products include all lots distributed February 16, 2017, to July 19, 2017, remaining within expiry, and they would be packaged in a syringe or IV bag. 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 a longstanding commitment to quality and safety. We are voluntarily issuing a recall out of an abundance of caution after several issues were identified during a recent inspection of our facility,” said Dell McCarley, Chairman and CEO of Cantrell Drug Company. “We regret any impact this recall has on our loyal customers and their patients.”
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
(Source: FDA)
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