Endo Pharmaceuticals has voluntarily recalled two lots of Robaxin (methocarbamol tablets, USP) 750mg tablets 100 count bottle packs over labeling issue.
The company is recalling two lots of Robaxin 750mg tablets 100 count bottle packs, as they have incorrect daily dosing information on the label.
Due to labeling error, the packs have misstated the daily dose as two to four tablets four times daily rather instead of correct dosage of two tablets three times daily.
Patients following the directions on the bottle will experience significant drowsiness or dizziness, which may keep them at risk of falls or an overdose that could result in seizures, coma, or death.
Endo noted that it has not received any reports of adverse events related to this recall to date.
Robaxin 750mg tablets are composed of active ingredient methocarbamol, and are used as an adjunct therapy to rest, physical therapy and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions.
The tablets are packed in bottles of 100 tablets, and the package labeling features product name, strength, lot number, expiry date and the National Drug Code number NDC 52244-449-10.
The recalled product lots include Robaxin 750mg 100 count bottle pack with lot number 216702P1 and expiration date of September 2020, as well as Robaxin 750mg, 100 count bottle pack with lot number220409P1 and expiration date of January 2021.
No other lots of Robaxin have been affected by the market action, said the company.
The wholesale distributors have supplied Robaxin 750mg 100 count bottle packs to retail pharmacies.
Endo notified to the distributors and retailers to write through Inmar, which will arrange for return of all recalled products.
Adverse reactions or quality problems experienced with the use of recalled product can be reported to FDA’s MedWatch Adverse Event Reporting program via on line, regular mail and fax.
Endo International, the parent firm of Endo Pharmaceuticals, is a global specialty pharmaceutical firm engaged in the development, manufacturing, marketing and distribution of branded and generic pharmaceutical products. It also supplies over-the-counter medications through its operating companies.