ImprimisRx NJ LLC — Class III: Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution, 10 mL per dropper bottl
ImprimisRx NJ LLC has initiated a Class III recall for Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution due to the product being identified as a subpotent drug. The recall affects 10 mL dropper bottles labeled for office use only.
This recall affects ImprimisRx NJ LLC, healthcare providers utilizing this ophthalmic solution for in-office procedures, and quality assurance teams responsible for monitoring drug potency and compounding standards.
A Class III recall indicates that the use of or exposure to the subpotent product is not likely to cause adverse health consequences; however, subpotency in an ophthalmic antiseptic/anesthetic combination could potentially impact the efficacy of clinical procedures. This suggests a need for the firm to investigate manufacturing or stability failures that led to the potency deviation.
Quality units should review potency testing protocols for ophthalmic solutions and verify that stability data supports the declared shelf life. Procurement and clinical operations should identify and quarantine affected lots of NDC 71384-732-10 to ensure subpotent material is not used in clinical settings.
Class III. Reason: Subpotent Drug. Product: Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution, 10 mL per dropper bottle, For Office Use Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-732-10. Firm: ImprimisRx NJ LLC (Ledgewood NJ United States). Status: Ongoing.
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