AvKARE Inc. has voluntarily recalled 8,328 bottles of Lamotrigine (100 mg) tablets because of a labeling error regarding the declared strength of the medication. The recall affects 1000-count bottles of the prescription drug distributed nationwide to pharmacies. No incidents or injuries have been reported to date in connection with this labeling error.
The error on the label means the declared strength may not accurately represent the actual dosage of the tablets inside the bottle. This could lead to a patient taking the wrong amount of medication, potentially resulting in ineffective treatment or unintended side effects.
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Rx Only. Manufactured for: AvKARE, Inc. Pulaski, TN 38478.
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Sources: FDA iRES · Raw API Response
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