USDA And Fedwatch Recall Alerts

TOPIC: One Lot of Healthy Living Over the Counter (OTC) Migraine Relief: Acetaminophen 250mg; Aspirin 250mg; Caffeine 65mg Tablets by Aurobindo Pharma USA: Recall – Due to Missing Manufacturer Label

AUDIENCE: Consumer, Health Professional, Pharmacy

ISSUE: Aurobindo Pharma USA Inc., on behalf of AuroHealth, is recalling one lot of Healthy Living Migraine Relief, Acetaminophen 250 mg, Aspirin 250 mg & Caffeine 65 mg tablets due to the product missing the manufacturer label.

Risk Statement: Amazon customers having purchased the recalled product will have a white unlabeled bottle from the manufacturer (AuroHealth) bearing only an Amazon identifying sticker. 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.

For more information about this recall, click on the red button “Read Recall“ below.

BACKGROUND: Healthy Living Migraine Relief, Acetaminophen, Aspirin & Caffeine tablets are indicated for temporary relief of minor aches and pains due to headache, a cold, arthritis, muscular aches, toothache, premenstrual and menstrual cramps.

RECOMMENDATIONS: 

• Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

• Consumers with medical questions regarding this recall or to report an adverse event can contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 (Option 2) or pvg@aurobindousa.com.

• Please contact Qualanex at 1-888-504-2014, for any general questions regarding the return of this product.

Health professionals and consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

Follow us on X at @FDAMedWatch