Glenmark Pharmaceuticals Inc., USA is recalling approximately 654,756 tubes of Tacrolimus Ointment, 0.1%, a prescription medication used for dermatological conditions. The recall was initiated because the product's container may be defective, with reports of the ointment tubes splitting along the side seam. A split tube can lead to ointment leaking out or the product becoming contaminated, which could affect how well the medicine works.
A split in the ointment tube compromises the sterile packaging of the medication and exposes it to the environment. This may lead to product contamination or leakage, although no injuries or adverse health events have been reported to date.
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Recall #: D-1304-2022
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Sources: FDA iRES · Raw API Response
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