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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.
Definition Hydrocodone and acetaminophen overdose occurs when someone accidentally or intentionally takes more than the normal or recommended amount of a painkiller containing both the opioid medication, hydrocodone, and acetaminophen (Tylenol). 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 Lorcet overdose; Lortab overdose Poisonous Ingredient Acetaminophen (Tylenol) Hydrocodone (narcotic) Where Found Acetaminophen with hydrocodone is the main ingredient in many prescription painkillers, including: Anexsia Anolor DH Lortab Lorcet Norco Vicodin Zydone Note: This list may not include all sources of hydrocodone and acetaminophen.
Earlier this month, the FDA's Anesthetic and Analgesic Drug Products Advisory Committee overwhelmingly voted against recommending approval of Zohydro ER, an extended-release version of hydrocodone. If approved, Zohydro ER would have been the first hydrocodone medication available that did not also contain a non-opioid analgesic such as acetaminophen or ibuprofen.
While the FDA does not have to follow the recommendation of its advisory committee, it usually does. The final determination is expected to be made by March 1, 2013.
Despite the fact that Zohydro ER was studied in nearly 1,500 patients––some for as long as a year––and found to be generally safe and well-tolerated with no new or unexpected safety problems, panel members expressed concerns with potential abuse, addiction and long-term safety.
It was noted that the manufacturer didn't offer any solution as to how they would limit unintended use other than the already tight distributio...
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