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| The United States: Endo Pharmaceuticals issues voluntary nationwide recall for two lots of Robaxin® 750mg Tablets 100 count bottle packs due to incorrect daily dosing information on label (English only) |
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The US Food and Drug Administration (FDA) announces that Endo Pharmaceuticals Inc., is voluntarily recalling two lots of Robaxin® (methocarbamol tablets, USP) 750mg Tablets 100 count bottle pack to the consumer level. The products have been found to have incorrect daily dosing information on the label due to a labeling error which misstates the daily dose as "two to four tablets four times daily" rather than the correct dosage of "two tablets three times daily."
Patients who follow the directions on the bottle may experience significant drowsiness or dizziness which would put them at risk of falls or an overdose which could result in seizures, coma, or death. To date, Endo Pharmaceuticals Inc. has not received any reports of adverse events related to this recall.
The recall includes the following product lots:
- Robaxin® 750mg, 100 Count Bottle pack, Lot 216702P1, Expiration Date: September 2020
- Robaxin® 750mg, 100 Count Bottle pack, Lot 220409P1, Expiration Date: January 2021.
No other lots of Robaxin® are affected by this market action.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/endo-pharmaceuticals-issues-voluntary-nationwide-recall-two-lots-robaxinr-750mg-tablets-100-count
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Wednesday, Jun 12, 2019
Issued at HKT 16:00
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