Endo Pharmaceuticals, Inc. recalls robaxin-750 (methocarbamol tablets, USP), 750 mg, 100-count bottle, Rx Only, Distributed by: Endo Pharmaceuticals Inc.,…

Recall date

September 17, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0009-2019

FDA classification

Class I

Brand / firm

Endo Pharmaceuticals, Inc.

Sold / distributed

Nationwide in the USA.

Why it was recalled

Labeling: Incorrect Instructions: Dosage information on the immediate container label incorrectly states "Two to four tablets four times daily." rather than the correct dosage of "Two tablets three times daily."

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

robaxin-750 (methocarbamol tablets, USP), 750 mg, 100-count bottle, Rx Only, Distributed by: Endo Pharmaceuticals Inc., Malvern, PA 19355; Manufactured by: Kremers Urban Pharmaceuticals Inc., a subsidiary of Lannett Company, Inc., Seymour, IN 47274; NDC 52244-449-10.