Warning Issued for Cantrell Drug Company Compounded Products
March 2, 2018 – A safety alert issued by the U.S. FDA warns patients and healthcare providers not to use any drug products made by Cantrell Drug Company of Little Rock, Arkansas. Affected products include opioids and compounds intended for sterile injection.
FDA investigators observed unsanitary conditions and violations of current Good Manufacturing Practice (CGMP) during an on-site inspection in June of 2017. Cantrell was advised to recall all drug products and complied in July 2017. According to the FDA, Cantrell has resumed drug production without adequately addressing the concerns identified during the June 2017 inspection.
Healthcare providers are advised to check their medical supplies and quarantine any drug products obtained from Cantrell. These products should not be administered to patients. Healthcare providers should also make alternative arrangements if they source drug products from Cantrell, and take steps to ensure suppliers operate under proper quality and safety standards. Any patient who may have received a drug product produced by Cantrell should contact their healthcare provider to discuss any concerns. Adverse reactions tied to Cantrell drug products should be reported to the FDA’s MedWatch program.
In addition to issuing a safety alert, the FDA has initiated legal action in an effort to prevent continued production and distribution of drugs by Cantrell, and to require a recall. Under a preliminary injunction filed in the U.S. District Court in the Eastern District of Arkansas, Cantrell would be able to resume production and distribution only after it has met the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.