Aurobindo Pharma USA, Inc., on behalf of AuroHealth, is voluntarily recalling one lot (AC2523005A) of Healthy Living Migraine Relief, Acetaminophen 250mg, Aspirin (NSAID) 250mg & Caffeine 65mg tablets, to the consumer level as sold through Amazon to known within the US market due to the product missing the manufacturer label.
Amazon customers having purchased the above product will have a white unlabeled bottle from the Manufacturer (AuroHealth) bearing only an Amazon identifying sticker, as shown below. As a result, the product lacks the required Over the Counter (OTC) labeling information, drug facts and patient usage information. There is significant risk of misuse which could result in permanent liver damage if consumers exceed the recommended dose, combine use with excessive consumption of alcohol or are allergic to the active ingredient which could be life-threatening. To date, Aurobindo has not received any reports of adverse drug events that are confirmed related to this recall.
Aurobindo Pharma USA, Inc. began shipping of the subject batch to customers nationwide in January 2024. AuroHealth Over the Counter (OTC) bottle(s) with no label affixed to the bottle (i.e. Brite Stock) was inadvertently supplied to Amazon, who then further placed an Amazon sticker with the product name and distributed the OTC product (without the Agency filed and approved label) to end users.
Healthy Living Migraine Relief, Acetaminophen, Aspirin (NSAID) & Caffeine tablets are indicated for temporarily relief of minor aches and pains due to: headache, a cold, arthritis, muscular aches, toothache, premenstrual and menstrual cramps.
As per the product information leaflet, Healthy Living Migraine Relief, Acetaminophen, Aspirin (NSAID) & Caffeine tablets are “White to off-white, capsule shaped, biconvex film-coated tablet debossed with “T” on one side and “57” on the other side. The product is packaged in 100 count bottles.