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.
Voluntary recalls were issued for specific lots of two opioid pain relievers and one medication for tension headaches. The affected drugs include:
Endocet (oxycodone/acetaminophen), 10/325 mg
Hydrocodone/acetaminophen, 7.5/500 mg
Butalbital/acetaminophen/caffeine, 50/325/40 mg
Endocet (oxycodone/acetaminophen) Endo Pharmaceuticals issued the nationwide Endocet recall because a bottle from each of two lots was found to contain some 10/650 mg tablets, which is twice the dosage of acetaminophen on the label. Because of this, consumers may take more than the intended acetaminophen dose. Possible Dangers: Unintentional administration of tablets with increased acetaminophen content may result in liver toxicity, especially in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day. Lots: The two lots affected are Lot # 402415NV and Lot # 402426NV. They were distri...
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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