Akron Pharma, Inc. is voluntarily recalling 4,416 tubes of Dibucaine 1% Hemorrhoidal Ointment (dibucaine) because of labeling errors where lot numbers and expiration dates are either incorrect or missing. The recall affects 1 oz. (28 gm) tubes distributed nationwide. No incidents or injuries have been reported, but consumers should contact a healthcare provider or pharmacist if they have health concerns.
Incorrect or missing labeling prevents consumers from knowing if the medication is still effective or if it has reached its expiration date. Using ointment past its intended shelf life could result in a lack of treatment efficacy for hemorrhoidal symptoms.
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Recall #: D-0454-2023; Manufactured for Akron Pharma Inc. Fairfield NJ 07004.
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Sources: FDA iRES · Raw API Response
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