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The FDA issued a notice that one lot of hydrocodone bitartrate and acetaminophen tablets with a dosage of 10 mg/500 mg has been recalled because some of them may contain a higher dosage of acetaminophen.
The affected tablets were manufactured by Qualitest, a subsidiary of Endo Health Solutions, and are from Lot Number C1440512A, with an expiration date of 12/13. The tablets are approximately 16.51 mm in length, pink, capsule-shaped tablets, with "3600" debossed on one side of the tablet and "V" on the other.
Unintentional administration of tablets with increased acetaminophen content could result in liver toxicity, especially in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than three alcoholic beverages a day.
If you are taking hydrocodone/acetaminophen in the 10/500 mg dosage and are not sure if your medication came from the recalled lot, check with your pharmacist.
Yesterday the U.S. Food and Drug Administration announced that it is asking manufacturers of prescription combination products that contain acetaminophen to limit the amount of acetaminophen to no more than 325 mg (milligrams) in each tablet or capsule. Acetaminophen is probably best known by the brand name Tylenol. Outside the U.S., it is often called paracetamol and on prescriptions it may be labeled as APAP (For example, hydrocodone APAP). The drugs most affected by this action are opioid pain relievers that are combined with acetaminophen like codeine (Tylenol #3), hydrocodone (Vicodin, Lortab) and oxycodone (Percocet). “FDA is taking this action to make prescription combination pain medications containing acetaminophen safer for patients to use,” said Sandra Kweder, M.D., deputy director of the Office of New Drugs in FDA’s Center for Drug Evaluation and Research (CDER). “Overdose from prescription combination products containing acetaminop...
Definition Acetaminophen overdose is one of the most common poisonings worldwide. People often think that acetaminophen, a pain-relieving medicine, is extremely safe. However, it may be deadly if taken in large doses. This is for information only and not for use in the treatment or management of an actual poison exposure. If you have an exposure, you should call your local emergency number (such as 911) or the National Poison Control Center at 1-800-222-1222. Alternative Names Tylenol overdose; Paracetamol overdose Poisonous Ingredient Where Found Acetaminophen is found in a variety of over-the-counter and prescription pain relievers. Tylenol is a brand name for acetominophen. Other medicines that contain acetominophen include: Anacin-3 Liquiprin Panadol Percocet Tempra Various cold and flu medicines Note: This list is not all inclusive. Common dosage forms and strengths: Suppository: 120 mg*, 125 mg, 325 mg, 650 mg Chewable tablets: 80 mg Junior tablets: 160 mg Regular strength: 325 mg Extra strength: 50...
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