Without evidence of benefit, an intervention should not be presumed to be beneficial or safe.

- Rogue Medic

Vicodin Labeled as Phenobarbital

If your patient is having breakthrough seizures, but insists that he has been taking his medication as prescribed, maybe this is a bit different from the usual seizure.

Generic drug manufacturer Qualitest Pharmaceuticals has notified the FDA that they have shipped some hydrocodone with acetaminophen (common brand names are Vicodin and Lortab) labelled as phenobarbital (common brand name Luminal). Patients should recognize the difference in the appearance of the medication, but people who just blindly put one from each container into their three times a day pill box containers may not notice that the tablet is not the same as the capsule they used to take. Different color, shape, size, texture, et cetera.

Others take a more traditional approach to medication administration.

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If we are wondering whether the patient has been taking the mislabeled hydrocodone with acetaminophen, the best way to find out is to ask the patient if the medication looks different. If the patient does not know, then find out who would. If nobody would know, ask to see the container.

How likely is it that this will be a problem that any of us encounter?

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.[1]

One bottle was found with the wrong label. That single case was found by the pharmacist filling the prescription.

The recall includes the following products:

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

Recalled lots were distributed between Sept. 21, 2010 and Dec. 29, 2010 to wholesale and retail pharmacies nationwide (including Puerto Rico).[1]

It is always good to think about the ways that things can go wrong, because sometimes they will. If we are not prepared when things do go wrong, the outcome will generally be worse than if we were prepared.

A quote attributed to Napoleon Bonaparte is –

Never interrupt your enemy when he is making a mistake.

By being prepared, we are more likely to interrupt our own mistakes.

Our patients will be grateful for this, even though they will probably never know.

Footnotes:

[1] Hydrocodone Bitartrate And Acetaminophen Tablets, Phenobarbital Tablets by Qualitest: Recall – Incorrect Package Labeling
FDA Safety Information
02/07/2011
Safety Information

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