• Food and Drug Administration
    Comprehensive Ophthalmology

    The FDA has removed approval for Par Pharmaceutical’s epinephrine formulation, Adrenalin®, for ophthalmic use. The company’s single-use 1-mL injection vials now contain tartaric acid, which has an unknown safety profile for intraocular or intracameral applications.

    Because of this change, physicians are advised to seek alternatives for mydriasis in ophthalmic surgery.

    Both physicians and patients should report adverse events following exposure to Adrenalin (epinephrine) injection 1-ml single-use vials to Par Pharmaceutical at 1-800-828-9393 or drugsafety@parpharm.com.