Label should read ‘two tablets three times daily,’ not ‘two to four tablets four times daily’
TUESDAY, Oct. 2, 2018 (HealthDay News) — Endo Pharmaceuticals is voluntarily recalling two lots of Robaxin (methocarbamol tablets) 750 mg tablets (100-count bottles) due to incorrect dosage information.
According to the recall notice, the products have incorrect daily dosing information on the label due to a labeling error that misstates the daily dose as “two to four tablets four times daily” rather than the correct dosage of “two tablets three times daily.”
The recall includes the following product lots: Robaxin 750 mg, 100 Count Bottle pack, Lot 216702P1, Expiration Date: September 2020; and Robaxin 750 mg, 100 Count Bottle pack, Lot 220409P1, Expiration Date: January 2021. No other lots of Robaxin are affected by this recall.
Significant drowsiness or dizziness may be experienced by patients who follow the incorrect directions. Following these directions could put them at risk for falls or an overdose, which could result in seizures, coma, or death. To date, Endo Pharmaceuticals has not received any reports of patient harm associated with the recall.
For more information about the recall, contact Endo Pharmaceuticals by phone at 1-800-462-ENDO (3636).
Endo Press Release
FDA Recall Notice
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