Huntsville-based Qualitest Pharmaceuticals, a generic pharmaceuticals provider, has issued a voluntary nationwide recall of Hydrocodone Bitartrate and Acetaminophen Tablets, as well as Phenobarbital Tablets.
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The move came after an individual bottle of Hydrocodone Bitartrate and Acetaminophen Tablets (USP 10mg / 500mg, NDC 0603-3888-20, 60 count, Lot Numbers T150G10B, T120J10E and T023M10A) was found incorrectly labeled with a Phenobarbital Tablets (USP 32.4 mg, NDC 0603-5166-32, 1000 count label, Lot Number T150G10B).
Lots T120J10E and T023M10A used the same stock inventory of labels as Lot T150G10B and are potentially impacted.
The recall is being made with the knowledge of the US Food and Drug Administration, and has been undertaken to prevent patients from unintentionally taking Hydrocodone and acetaminophen tablets instead of the intended dose of Phenobarbital.
No injuries have been reported to date, and Qualitest is notifying all customers who may have received affected product and arranging for the return of any affected product.
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