K.C. Pharmaceuticals recalled 315,144 sterile eye drop bottles distributed nationwide after lack of sterility. The products span several brands including GNP Eye Drops Redness and Dry Eye Relief, Leader Eye Drops Redness Relief, and Foster & Thrive Redness Relief Eye Drops. Consumers should stop using the products immediately and follow guidance from KC Pharmaceuticals or their healthcare provider
Lack of Assurance of Sterility
Consumers and healthcare providers should stop using this product immediately. Contact K.C. Pharmaceuticals, Inc or your healthcare provider for guidance. Notification method: E-Mail
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These eye drops are marketed as sterile relief for redness and dryness. They are sold under multiple brand names and distributed across the United States by various distributors.
A sterility lapse means the product could be contaminated, potentially causing eye infections or injuries if used.
This recall is not part of a broader industry pattern.
Impact includes a large nationwide distribution of recalled bottles. The primary risk is potential eye infection or irritation from non-sterile product.
Recall details available on FDA enforcement page and the notice from KC Pharmaceuticals.
4-8 weeks for refund or replacement processing once arranged.
Retain the product, packaging, and recall notice. Save all correspondence with KC Pharmaceuticals and your healthcare provider.
Product: Sterile Eye Drops Redness Relief Lubricant (glycerin 0.25% and napahazoline HCl 0.012%), 0.5 fl oz (15 mL). Size: 0.5 fl oz (15 mL). Brands involved: GNP Eye Drops Redness and Dry Eye Relief; Leader Eye Drops Redness Relief; Foster and Thrive Redness Relief Eye Drops. Distributors and packaging identifiers include KC Pharmaceuticals, Inc and nationwide distributors such as AmerisourceBergen, Cardinal Health, Grandall Distributing Co., Walgreens, McKesson Corp., UNFI, Rite Aid, Discount Drug Mart. UPC/NDcs and packaging identifiers include: UPC 130209; NDC 46122-606-05; Colirio Ojo
No injuries or incidents have been reported.
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