Approximately 710,040 bottles of Tramadol Hydrochloride (50 mg) tablets, including both brand name and generic versions, are being recalled because the patient information leaflet contains incorrect dosing instructions. The leaflet describes a process for splitting the tablets to reach a 25 mg dose; however, the tablets provided in these bottles are unscored and cannot be safely split into smaller doses. This recall affects 379,043 of the 100-count bottles and 330,997 of the 500-count bottles distributed across the United States between 2019 and 2021.
Patients attempting to split these unscored tablets to follow the 25 mg dosing instructions in the leaflet may receive an inaccurate or inconsistent amount of medication. This poses a risk of incorrect dosing for patients who require titration as part of their treatment.
Golden State Medical Supply is offering refunds for the affected products.
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Sources: FDA iRES · Raw API Response
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