FDA Recall: Vicodin (Hydrocodone Bitartrate) in Phenobarbital Bottles Qualitest Pharma-Incorrect Package Labeling
Posted Feb 10 2011 6:50pm
If you were a patient taking phenobarbital for seizures and have the wrong drug you may not get the the desired relief with hydrocodone. Also this is a combination drug with acetaminophen so concerns for those with seizures and any liver dysfunctions. This looks not to be too big but not too long ago we heard about this happening with Glaxo which resulted in a huge lawsuit and more. Sharp pharmacists though might be able to catch this before anything gets dispensed hopefully.
And yet one more post to substantiate bar coding drugs and medical devices for easy identification for recalls. Click on the bar code campaign for more information or the image below. BD
ISSUE: An individual bottle of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg / 500mg, NDC 0603-3888-20, 60 count was found incorrectly labeled with a Phenobarbital Tablets, USP 32.4 mg, NDC 0603-5166-32, 1000 count label, printed with Lot Number T150G10B. Both products are manufactured by Qualitest Pharmaceuticals.
As a result of this mix-up, patients may unintentionally take Hydrocodone and acetaminophen tablets, instead of the intended dose of Phenobarbital. Unintentional administration of Hydrocodone can lead to serious adverse events including respiratory depression, CNS depression, coma and death, especially in opioid naïve patients and patients on other CNS depressants. Unintentional administration of acetaminophen may result in liver toxicity in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day. Additionally, missing doses of Phenobarbital could result in loss of seizure control.
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg / 500mg, NDC 0603-3888-20, 60 count, Lot Numbers T150G10B, T120J10E and T023M10A
Phenobarbital Tablets, USP 32.4 mg, NDC 0603-5166-32, 1000 count, Lot Numbers T150G10B, T120J10E and T023M10A