FDA Acetaminophen Limits in Combination Products
Effective January 14, 2014, it will become unlawful to purchase or sell any narcotic/acetaminophen combination products that contain greater than 325mg of acetaminophen. This ban on high dosage acetaminophen in prescription combination products was first passed by the FDA in January 2011. There will not be a recall on these products.
AMS would like for physicians to be aware of this change and to get your patients proactively switched to combination products that contain 325mg or less of acetaminophen. For additional information on this change you can visit the FDA’s Press Release on this change.