K.C. Pharmaceuticals, Inc. — Class II: Sterile Lubricant Dry Eye Relief Eye Drops, 0.5 FL OZ (15 mL); a) LEADER, DISTRIBUTED BY C
K.C. Pharmaceuticals, Inc. has initiated an ongoing Class II recall for multiple brands of Sterile Lubricant Dry Eye Relief Eye Drops (15 mL) due to a lack of assurance of sterility. Affected brands include Leader, Crocodile Tears, Discount Drug Mart, Exchange Select, Geri Care, H.E.B, Harris Teeter, Foster & Thrive, and TopCare Health.
This recall impacts K.C. Pharmaceuticals, Inc., third-party distributors (including Cardinal Health and McKesson), retail pharmacies, and quality assurance personnel responsible for sterile ophthalmic manufacturing oversight.
A lack of sterility assurance in ophthalmic products represents a significant clinical risk due to the potential for ocular infection. For regulatory professionals, this multi-brand recall suggests potential systemic issues in the manufacturing or fill-finish process at the Pomona facility, which may trigger broader FDA scrutiny of the firm's quality management system and aseptic controls.
Immediately identify and quarantine all affected NDCs and UPCs within the supply chain. Conduct a thorough investigation into the root cause of the sterility assurance failure and review environmental monitoring and aseptic processing validation data for the Pomona facility.
Class II. Reason: Lack of Assurance of Sterility. Product: Sterile Lubricant Dry Eye Relief Eye Drops, 0.5 FL OZ (15 mL); a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0502-1; b) Crocodile Tears, Distributed by: Crocodile Tears, Palm Beach Gardens, FL 33410, UPC: 8 67166 00000 4; c) Discount drug mart, Discount Drug Mart Food Fair, Medina, OH 44256, UPC: 0 93351 01156 6; d) exchange select, Manufactured for your Military Exchange By: K.C Pharmaceuticals, Inc., Pomona, CA 9176, UPC: 6 14299 05620 6; e) GERI CARE, Distributed by: Gericare Pharmaceuticals Corp., 1295 Towbin Ave., Lakewood, NJ 08701, NDC 57896-181-05; f) H.E.B Dry Eye, Eye Drops, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43741 2; g) Harris Teeter, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATTHEWS, NC 28105, UPC: 0 72036 71303 2; h) Foster & Thrive, Distributed by: McKesson Corp. Via Strategic Sourcing Servies LLC., Memphis, TN 38141, NDC 70677-1157-1; I) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 36100 3.. Firm: K.C. Pharmaceuticals, Inc. (Pomona CA United States). Status: Ongoing.
Open in openFDA / FDA.gov