FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA, DOJ File Complaint Against Arkansas Compounder Following GMP Deviations

March 6, 2018

Following FDA inspections and a warning letter, the Department of Justice filed a civil complaint against the outsourcing facility Cantrell Drug Company, of Little Rock, Arkansas seeking a preliminary injunction to halt manufacturing and order the company to recall and destroy all drugs compounded, held or distributed.

At the same time, the FDA alerted health care professionals and patients not to use the company’s products, including opioids and other sterile injectables.

The complaint, filed at the FDA’s request, claims the firm distributed drugs prepared, packed or held under insanitary conditions and failed to comply with cGMP regulations. Cantrell initiated voluntary recalls in 2016 and 2017 following compromised sterility assurance. The 2017 recall encompassed all lots of sterile drug products distributed over a period of five months.

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