JUL 11, 2018
Cataract/Anterior Segment, Comprehensive Ophthalmology, Cornea/External Disease, Glaucoma, Neuro-Ophthalmology/Orbit, Ocular Pathology/Oncology, Oculoplastics/Orbit, Pediatric Ophth/Strabismus, Refractive Mgmt/Intervention, Retina/Vitreous, Uveitis
Due to lack of sterility assurance, the FDA is urging healthcare professionals not to use sterile drug products produced and distributed by Ranier’s Compounding Laboratory, Ranier’s Pharmacy and Ranier’s RX Laboratory, Jeannette, Pennsylvania.
In their statement, the FDA noted that investigators observed unsanitary conditions, including poor sterile production practices, during a recent inspection of the compounding facility. The agency had previously issued a warning letter to Ranier’s Compounding over similarly unsatisfactory conditions in March 2017.
On June 6, 2018, the FDA recommended that Ranier’s Compounding recall all unexpired and sterile drug products, and to cease sterile operations until it makes adequate corrections at its facility. On June 7, 2018, Ranier’s Pharmacy agreed to voluntarily recall and cease sterile operations. However, the company has failed to follow through with its commitment.
Health care professionals should immediately check their medical supplies, quarantine any purportedly sterile drug products, and not administer them to patients. To date, the FDA is unaware of any adverse events associated with the use of products from Ranier’s Compounding.
Physicians and patients can report adverse reactions or quality issues to the FDA through the MedWatch Adverse Event Reporting site or by mail or fax (1-800-FDA-0178).