Two drug manufacturers have recalled a number of products that contain acetaminophen because of mislabeling that could result in overdoses.
Endo Pharmaceuticals recalled two lots of Endocet (oxycodone/acetaminophen) tablets, 10 mg/325 mg (100-count), after bottles from each lot were found to contain some 10 mg/650 mg formulation pills, a company statement said.
Qualitest Pharmaceuticals recalled four lots of their generic butalbital, acetaminophen, and caffeine tablets, 50 mg/325 mg/40 mg (500-count) and four lots of their hydrocodone bitartrate and acetaminophen tablets, 7.5 mg/500 mg (1,000-count) after a bottle of the former was found with a label from the latter, a statement from the company said.
The Qualitest recalls affect lots C0390909A, C0400909A, C0410909A, and C0590909B of the butalbital/acetaminophen/caffeine combination, and lots C0390909A, C0400909A, C0410909A, and C0590909B of the hydrocodone bitartrate/acetaminophen combo.
The Endo recall affects lot numbers 402415NV and 402426NV.
Patients can differentiate between the two Qualitest products by looking for a white, round-shaped tablet with "2355" debossed on one side on the butalbital/acetaminophen/caffeine tablets. In contrast, the hyodrocodone bitartrate/acetaminophen tablets are white with green specks, capsule-shaped, and debossed with "3594" on one side.
In the Endocet formulations, the 10 mg/325 mg tablets are capsule-shaped, with an "E712" marking on one side and a "10/325" marking on the other. The 10 mg/650mg tablet is oval, with an "E797" marking on one side and "10" on the other.
Accidental dosage of the three-drug Qualitest combination tablet may result in sedation, lightheadedness, dizziness, nausea, hypersensitivity, tremors, irritability, and difficulty sleeping, but patients may also experience withdrawal symptoms and worsening of pain if doses of the hydrocodone drug are missed.
Patients who take the elevated dose of acetaminophen accidentally may experience liver toxicity or severe liver damage.
Each company asked patients to stop using the affected product and return it to the manufacturer.
Meanwhile, McNeil Consumer Healthcare had recalled yet another lot of Tylenol Extra Strength Caplets because of a musty odor. The recall affects 225-count bottles in lot ABA619 and includes 60,912 bottles.