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21 Feb 2024

Case Study: Product Recall due to labeling error

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In the pharmaceutical market we find many cases where product recall takes place due to labeling error. Here is an example.

Company XYZ is voluntarily recalling two lots of Brand ABAC (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.

Brand ABAC 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. Brand ABAC 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 xxxxx-xxxx-xx.

The recall includes the following product lots: Brand ABAC 750mg, 100 Count Bottle pack, Lot XXXXXXX, Expiration Date: <date>; and Brand ABAC 750mg, 100 Count Bottle pack, Lot YYYYYYYY, Expiration Date: <date>.

Comapny XYZ must notify 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).

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