Methocarbamol Tablets for Treating Musculoskeletal Conditions are Recalled

OCTOBER 01, 2018
Two lots of Robaxin® (methocarbamol tablets, USP) 750mg Tablets 100 Count Bottle pack are being voluntarily recalled by Endo Pharmaceuticals Inc., due to incorrent dosing information on the label.

Robaxin® 750mg Tablets contain the active ingredient methocarbamol and are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions, as an adjunct therapy to rest, physical therapy and other measures.

The labeling error misstates the daily dose as "two to four tablets four times daily" rather than the correct dosage of "two tablets three times daily," according to the FDA. The recalled products include Robaxin® 750mg, 100 Count Bottle pack, Lot 216702P1, Expiration Date: September 2020; and Lot 220409P1, Expiration Date: January 2021. No other lots of Robaxin® are affected by this market action.

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, according to the FDA.

Robaxin® 750mg 100 Count Bottle packs were distributed by wholesale distributors to retail pharmacies. Distributors and retailers that have product which is being recalled should stop distributing and dispensing and return to the place of purchase.

Consumers in possession of any unused prescribed Robaxin® 750mg product bearing lot numbers 216702P1 or 220409P1 should discontinue use of the product. A physician or healthcare provider should be contacted in the event of any problems that may be related to taking or using this drug product.

Unused products can be returned by distributors, retailers, and consumers. Call intermediary Inmar at 1-866-391-0620 or email robaxin@inmar.com for instructions.


Reference

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 [news release]. Silver Spring, MD. October 1, 2018: FDA website. http://www.pharmacytimes.com/link/223. Accessed October 1, 2018.

 

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