Fagron Compounding Services recalled 2,980 syringes of a topical ophthalmic solution on November 20, 2025. The recall stems from an incorrect product formulation that could pose health risks. Consumers should stop using the product immediately and contact their healthcare provider for guidance.
Incorrect Product Formulation
Consumers and healthcare providers should stop using this product immediately. Contact Fagron Compounding Services or your healthcare provider for guidance. Notification method: Letter
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The product is a topical ophthalmic solution used for eye care, including pupil dilation and inflammation control. Consumers typically buy this for procedures or conditions requiring eye examination or treatment.
The product's incorrect formulation could lead to ineffective treatment or adverse reactions in patients. It is crucial to use properly formulated medications for ocular applications.
This recall is not part of a broader industry pattern.
The recall poses a high health risk, necessitating immediate cessation of use and consultation with healthcare professionals for any consumers who have used the product.
You can find serial numbers and lot numbers on the packaging of the syringe, typically near the expiration date.
Expect a timeline of approximately 4-6 weeks for processing refunds or replacement.
Keep all receipts, correspondence regarding the recall, and any medical advice received.
The affected product is Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, packaged in 0.5mL single-use syringes. It is distributed by Fagron Sterile Services, located at 8710 E 34th St N, Wichita, KS 67226. The National Drug Code (NDC) is 71266-8240-01.
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