Incorrect Package Labeling Causes Qualitest Pharmaceuticals to Initiate Recall

An FDA MedWatch Alert has announced that Qualitest Pharmaceuticals is recalling Hydrocodone Bitartrate/Acetaminophen and Phenobarbital Tablets due to incorrect package labeling. The recall was initiated after an individual bottle of Hydrocodone Bitartrate and Acetaminophen Tablets was discovered with the wrong label. It had a Phenobarbital Tablets label instead of its Hydrocodone Bitartrate and Acetaminophen label.

The improper labeling of pharmaceutical products puts patients at risk of accidentally consuming the incorrect medication. In this case serious adverse reactions, such as respiratory depression, CNS depression, coma, and death can be caused by unintentional administration of Hydrocodone. In addition, patients who unintentionally take Acetaminophen may respectively suffer liver toxicity if they are on other acetaminophen medications or consume more than three alcoholic beverages per day. Another potential risk associated with this particular drug mislabeling is an increased risk of seizures in patients who miss their doses of Phenobarbital because they took the wrong medication.

The following products are included in the recall:

  • 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 side of the bottle of these medications contains the lot numbers. These products were put on the market between Sept. 21, 2010 and Dec. 29, 2010 to wholesale and retail pharmacies throughout the nation and in Puerto Rico. Consumers are advised to stop using these pharmaceutical products and contact Qualitest at 1-800-444-4011 for reimbursement.

As New Jersey product liability attorneys, we are familiar with the potential harmful effects of manufacturing defects, poor product design, and improper labeling; and we have the expertise required to properly pursue these complex product liability matters. At Blume Forte, we are committed to protecting the rights of injured victims. For a free consultation about your potential product liability claim, call our firm at 973-635-5400.

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