Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin® 750mg Tablets 100 Count Bottle Packs

PUBLISHED: Oct 1, 2018
Relevant to: Ambulatory Care, Critical Access Hospitals, Hospitals, Medical Office, Pharmacy

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." See the recall notice for a picture of the location of incorrect text on the label.

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.

Robaxin® 750mg Tablets contain the active ingredient methocarbamol and are indicated as an adjunct therapy to rest, physical therapy and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. Robaxin® 750mg Tablets are packed in bottles of 100 tablets with package labeling featuring the product name, strength, lot number, expiry date and the National Drug Code number NDC 52244-449-10.

The recall includes the following product lots:

  • Robaxin® 750mg, 100 Count Bottle pack, Lot 216702P1, Expiration Date: September 2020; and
  • Robaxin® 750mg, 100 Count Bottle pack, Lot 220409P1, Expiration Date: January 2021.

No other lots of Robaxin® are affected by this market action.

Robaxin® 750mg 100 Count Bottle packs were distributed by wholesale distributors to retail pharmacies.

Endo Pharmaceuticals Inc. is notifying distributors and retailers in writing through Inmar, Inc. Inmar is arranging for return of all recalled products.

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 and return the unused product by following the instructions outlined in the recall notice.

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