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Class I Recall for Muscle Relaxant

October 12, 2018

A labelling mistake has prompted Endo Pharmaceuticals Inc. to recall two lots of Robaxin (methocarbamol tablets, USP) 750-mg tablets in 100-count bottles (NDC 52244-449-10), according to the October 10, 2018, US Food and Drug Administration (FDA) Enforcement Report. Bottle labels erroneously state the daily dose as “two to four tablets four times daily" rather than the correct dosage of "two tablets three times daily.”

The FDA has designated the recall Class I, indicating a reasonable probability that use of the product as labelled could cause serious adverse health consequences or death.

“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 company stated in a September 28, 2018, press release.

The recall affects 2856 bottles from lots 216702P1 (Exp. 9/20) and 220409P1 (Exp. 1/21). The tablets, manufactured by Kremers Urban Pharmaceuticals Inc., were distributed across the United States.

Endo Pharmaceuticals voluntarily initiated the recall September 17, 2018.

Robaxin-750 is a prescription medication indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions.

Jolynn Tumolo

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