FDA Warns Against Use of Drug Products Due to Lack of Sterility

The FDA is urging veterinarians and other animal health care professionals to check their medical supplies and quarantine any “sterile” drug products produced by Ranier’s Compounding Laboratory—also known as Ranier’s Pharmacy and Ranier’s RX Laboratory, Jeannette, Pennsylvania.

According to the administration, the company’s human and animal drug products have been classified as unsafe due to lack of sterility assurance. To date, no human or animal illnesses have been reported in relation with any of the company’s products.

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The FDA issued a warning letter to Ranier’s Compounding in March 2017 after investigators observed unsanitary conditions and poor sterile practices during an inspection of the company’s compounding facility.

“Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death,” the FDA wrote in a statement.

For this reason, the FDA recommended on June 6, 2018 that Ranier’s Compounding recall all of its unexpired human and animal drug products intended to be sterile and stop all sterile operations until adequate corrections were made to its compounding facility.

While the company agreed to the voluntary recall the following day, the FDA says Ranier’s Compounding has failed to comply with its commitment.

Ranier’s Compounding has produced various compounded veterinary drugs, including behavior, cardiology, dermatology, endocrinology, pain management, seizure, equine, and avian medications.

Practitioners are urged to report any adverse reactions or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting Program.