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...
Do you take acetaminophen (Tylenol) for Migraines or other issues, either by itself or as part of another medication?
If you do, you need to know about a new warning issued by the Food and Drug Administration (FDA) about a rare risk.
The FDA published this warning statement:
Acetaminophen, a fever and pain reliever that is one of the most widely used medicines in the U.S., can cause rare but serious skin reactions, warns the Food and Drug Administration (FDA).
Although rare, possible reactions to acetaminophen include three serious skin diseases whose symptoms can include rash, blisters and, in the worst case, widespread damage to the surface of skin. If you are taking acetaminophen and develop a rash or other skin reaction, stop taking the product immediately and seek medical attention right away.
Used for decades by millions of people, acetaminophen is the generic name of a common active ingredient included in numerous prescription and non-prescription ...
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