Akorn, Inc. is recalling 45,117 bottles of Atropine Sulfate Ophthalmic Solution (USP 1%). This voluntary recall was issued because the product failed a 12-month stability test for viscosity, meaning the liquid may not have the correct thickness. This affect only 2 mL sterile bottles distributed nationwide in the USA and Puerto Rico under NDC 17478-215-02.
A failure in viscosity specifications means the eye drops may not behave as expected when applied to the eye, potentially impacting how the medication is absorbed or dispensed. The risk to consumers is considered low, and no injuries have been reported.
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Distributed by Akorn Operating Company LLC
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Sources: FDA iRES · Raw API Response
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