Imprimis NJOF, LLC has recalled 6,228 bags + 15,360 boxes of Mydriatic-4 (Tropicamide, Proparacaine, Phenylephrine, and Ketorolac) Sterile Ophthalmic Solution. The recall was initiated because the Ketorolac component of the medication was found to be subpotent, containing less of the active ingredient than specified on the label. This prescription eye drop solution is distributed to and used by healthcare professionals in physician's offices.
Because the medication is subpotent, it may not be as effective as intended for patient treatment. No injuries or adverse incidents have been reported in connection with this recall.
MDU stands for Multi-Dose Unit; SDU stands for Single-Dose Unit.
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Sources: FDA iRES · Raw API Response
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