Qualitest Pharmaceuticals Recalls Hydrocodone Bitartrate, Acetaminophen and Phenobarbital Tablets

Qualitest Pharmaceuticals logoQualitest Pharmaceuticals is recalling certain lots of Hydrocodone Bitartrate and Acetaminophen Tablets, as well as Phenobarbital Tablets. A bottle of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg / 500mg, NDC 0603-3888-20, 60 count was found incorrectly labeled as Phenobarbital Tablets, USP 32.4 mg, NDC 0603-5166-32, 1000 count, printed with Lot Number T150G10B. Lots T120J10E and T023M10A used the same stock inventory of labels as Lot T150G10B and could also be affected.

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.

As a result of this mix-up patients may unintentionally take Hydrocodone and acetaminophen tablets, instead of the intended dose of Phenobarbital.

No injuries have been reported to date.

Consumers who have affected product should stop using the product and contact Qualitest at 1-800-444-4011 for reimbursement and more information. The lot number can be found on the side of the bottle.

This recall includes the following pharmaceutical drugs from Qualitest:

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

The recalled pills were distributed between 12/21/2010 12/29/2010 to wholesale and retail pharmacies nationwide (including Puerto Rico). Lot numbers can be found on the side of the bottle. Hydrocodone Bitartrate and Acetaminophen Tablets are large (approximately 16.5 mm in length), pink, capsule-shaped tablets, debossed (3600) on one side, and debossed (V) on the reverse side; Phenobarbital Tablets are small (approximately 6.4 mm in diameter), white, round, biconvex, scored tablets, debossed (5012) and (V) on one side and plain on the reverse side. All patients who have filled prescriptions of Phenobarbitol manufactured by Qualitest, are asked to double check the identity of their tablets.

Qualitest is notifying all customers who may have received affected product and arranging for the return of any affected product. Consumers with questions may contact Qualitest at 1-800-444-4011 for more information.

Adverse reactions or quality problems experienced with the use of this product may be reported to the manufacturer or to FDA’s MedWatch Adverse Event Reporting program at 1-800-444-4011.

There are 7 comments. Add yours.

  1. Cynthia Francis

    Watson pharmaceutical has the best quality medicines. I have taken Qualitest meds and they are ” watered down “. ( not worth a damn ). I have been taking pain meds with my other meds since 2000. If the FDA wants to make changes with hydrocodone/acetaminophen 10-500 to the 10-325, we need to have one dosage more than what we have been taking. This would compensate due to less painkiller ingredient that is new. We have to stay away from over-the-counter meds that contain Acetaminophen and alcohol.

  2. David

    Class action law suit?????? Two years finding out about this is ridiculous!!!!!!

  3. Pamela

    I have been taking Lortab 10/500 for the last 7 years and xanax 1mg also.Now my doctor is saying he cant write them and substituted the Lortab with Norco 10/325.I don’t like the Norco because they make me feel weird.They make me feel high and I get sick when I get a high feeling,I start throwing up.The Lortab and xanax do me fine as far as taking my pain away.I take the pink Lortab that have 3600 on them.I have Fibromyalgia and a chronic case of it.I NEED MY MEDS.

  4. ricko

    my wife got her xanax and vicodin filled and the generic was your qualitiest brand. she took her xanax and said she did not feel anything, not ever the slight side effects. Same with her pain meds.. So being from a younger generation i was not unfamiliar with these drugs, just had no feeling to abuse now that i have grown to be a man…up to help prove my wife was not crazy i took two 1mg xanax. and sure enough nothing. then i did some research on the web and it said that your brand was kind of well “shitty” sorry about the language but i work hard hor my money and insurance and cant stand my wife not getting taken care of. good thing it was not her thyroid meds. How about a sorry at least??????

  5. stacy

    Alprazolam made by your company has sent me to the ER several times for my anxiety/panic disorder. IF indeed they did their job to calm an anxious person down, I would not have had to spend hours in the ER and pay out of pocket my ER deductible many times.
    I have since switched to MYLAN mfr. and they actually seem to calm me down.
    I would like to know if there is any way to refund ALL the co-pays, the suffering of panic attacks, hosp co-pays and deductibles, days off work…etc. due to panic attacks while taking your placebo xanax?????????????????????

  6. Pamela Costello

    Everytime I have to use hydrocodone/apap in from your company I suffer in severe pain because they don’t work as well as the company my pharmacy usually uses. please explain what the problem might be. I can only use one pharmacy because of doctor regulations so I have no choice if they have to substitute name brands. I depend on my meds to work, but there is definitly something wrong with your brand of hydrocodone/apap.

  7. judy arvin

    my last few refills of alprazolam made by your co. have something wrong they have no effect at all. i use rite aid drug store in irvine,ky.
    icalled them and ask why each month i get a different color and mine have’t been working for months and they said they just have to take whatever they are sent them.
    for years i took greenstone and watson they worked fine.

    n the last 3 months i have recieved a different color each month, why?

    Judy K. arvin


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