Fagron Compounding Services has recalled 756 bottles of a compounded ophthalmic (eye) solution containing Tropicamide, Cyclopentolate, Phenylephrine, and Ketorolac. The label on the 5 mL dropper bottle incorrectly states that the container is a 0.5 mL single-use syringe. This recall affects products distributed nationwide to hospitals and medical offices.
The label mix-up may cause confusion regarding the volume of the medication or the correct method of administration. Incorrect use or dosing confusion could lead to potential eye irritation or ineffective treatment, although the current risk level is categorized as low.
Label mistakenly states the container is a 0.5mL single-use syringe instead of a 5 mL dropper. Labeled for Hospital & Office Use Only.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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