Compounded Drug Products from Cantrell Drug Company: FDA Warning Serious Deficiencies in Quality and Sterility Assurance
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On March 1, 2018 the Food and Drug Administration issued a statement alerting health care professionals and patients not to use compounded drug products produced by Cantrell Drug Company of Little Rock, Arkansas. The statement suggested that the FDA is concerned about serious deficiencies in Cantrell’s compounding operations, including its processes to ensure quality and sterility assurance. Issues within these processes have the potential to put patients at risk for severe injury or death.
Who is Cantrell?
Cantrell Drug Company specializes in sterile product compounding of intravenous (IV) medications and drug shortage injections for hospitals, surgery centers and physician groups. The company provides sterile injectable pharmaceuticals that are primarily used in hospitals. In many cases these pharmaceuticals are in critical demand or require compounding to prepare the medication in a final form for administration to patients. Cantrell’s products also offer significant cost savings to hospitals who are under tight budget constraints.
What is the Issue?
FDA is alerting health care professionals and patients not to use drug products produced by Cantrell, citing serious deficiencies in quality and sterility assurance. Some of these products have been distributed nationwide to various healthcare facilities, and as such affected products have the potential to reach a vast number of vulnerable patients. Administration of contaminated or otherwise poor-quality drug products can result in serious and life-threatening injury or death.
Cantrell’s facility was most recently inspected by the FDA in June 2017, where the inspectors observed poor compounding drug operations. The FDA investigators observed insanitary conditions and violations of current Good Manufacturing Practice (CGMP) that could cause Cantrell’s drugs to become contaminated or made injurious to health. Such conditions are of grave concern, given the nature of products that Cantrell’s facility produces.
Taking Action Against Cantrell
The Department of Justice, in conjunction with the FDA, has requested a court order requiring Cantrell to stop manufacturing, processing, packing, labeling, holding and/or distributing any drugs until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its regulations. The proposed order also will require Cantrell to recall all non-expired drug products on the market.
Products Produced by Cantrell and Possibly Affected:
- Ephedrine Syringe– This medication is used in emergencies to treat very serious allergic reactions to insect stings/bites, foods, drugs, or other substances.
- Glycopyrrolate Syringe– An additional agent to induce anesthesia.
- Lidocane HCl Syringe– Product is specifically indicated in the acute management of ventricular arrhythmias such as those occurring in relation to acute myocardial infarction, or during cardiac manipulation, such as cardiac surgery.
- Morphine Syringe– An opioid, this medication is used to treat severe pain.
- Norepinephrine Bag- IV– Norepinephrine is used to treat life-threatening conditions such as shock and low blood pressure.
- Phenylephrine Syringe– A prescription drug used for the maintenance of blood pressure during treatment of vascular failure in shock, drug-induced high blood pressure, and PSVT during anesthesia.
- Rocuronium Bromide Syringes and Succinylcholine Chloride Syringes – Medications used to relax muscles during surgery and medical procedures.
- Vancomycin Solution Oral Syringe– An antibiotic used to treat infection.
The FDA is urging all health care professionals to immediately check their medical supplies, quarantine any drug products from Cantrell Drug Company and cease use of such products in treating patients. Health care professionals who obtained products from Cantrell should make other efforts to obtain medications they administer or dispense to patients from sources that adhere to proper quality standards.
Patients who have received any drug product produced by Cantrell and have concerns should contact their health care provider to discuss their situation. Healthcare professionals and patients are encouraged to report any adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
Have You Suffered After Using Cantrell Pharmaceutical Products?
If you have suffered injury after using any pharmaceutical products from Cantrell Drug Company, it is important that you speak with your medical provider as to any necessary steps to ensure your health and safety, and that you file a report with the FDA. It may also be important to consult with an experienced medical device liability regarding your claim and your rights to compensation. For more information call the product liability attorneys at the Law Offices of Peter Angelos today.