Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistUnit Dose Services, LLC failed to comply with drug listing requirements under 21 CFR 207.49(a)(15)(ii) for their Lisinopril product (NDC 50436-0353). The company submitted an incorrect carton label image to FDA's electronic Drug Registration and Listing System that did not match the actual product—specifically, the uploaded label image referenced "Pharbetol-Acetaminophen" while the electronic listing file referred to Lisinopril, creating a mismatch between the active ingredients shown on the label and those listed in the submission. Despite FDA's deficiency letter on March 15, 2022 and a subsequent data removal notification on April 29, 2022, the company failed to correct the violation, resulting in the product's removal from FDA's Online NDC Directory.