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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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
Hazard: Lack of Assurance of Sterility. Using these eye drops could pose a risk of eye infection or other sterility-related harm. The recall notes this is a Class II recall.
No injuries or incidents have been reported.
1) Stop using the product. 2) Contact KC Pharmaceuticals, Inc. or your healthcare provider for guidance via the recall notice email. 3) Monitor for eye redness, pain, discharge or vision changes and seek medical care if symptoms appear. 4) Keep packaging and lot information for reference. 5) For refunds or replacements, follow guidance provided in the recall notice via KC Pharmaceuticals.
KC Pharmaceuticals, Inc. recall notice email (no public phone number or website provided in the source).
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