3 Oct 2018

Case Study: Product Recall due to labeling error

Posted Byadmin

Comments0

Tagsclass i recall, FDA's role in product recall, medicine labeling, Product Recall, Produt recall, What is class i Recall

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 labelling 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.”

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.

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.

This Product Recall is being made with the knowledge of the United States Food and Drug Administration (FDA).