East Windsor, New Jersey-based Aurobindo Pharma USA, Inc. has recalled a single lot of Healthy Living Migraine Relief, Acetaminophen 250mg, Aspirin (NSAID) 250mg & Caffeine 65mg tablets on behalf of AuroHealth because the product does not have a manufacturer label, reports the FDA.
The voluntary, consumer-level recall was initiated by the company on July 18, 2024, and announced on the FDA website on July 24, 2024. It covers 100-count bottles that were made available for purchase on Amazon throughout the U.S. market. Affected bottles can be identified through NDC 58602-882-21, Lot number AC2523005A, and Expiry date June 2025.
Indicated for the short-term relief of minor aches and pains associated with a “headache, a cold, arthritis, muscular aches, toothache, premenstrual and menstrual cramps,” Healthy Living Migraine Relief, Acetaminophen, Aspirin (NSAID) & Caffeine tablets are “white to off-white” in color and come in the shape of biconvex capsules that are film-coated and de-bossed with “I” on one side and “57” on the reverse side. Every bottle contains 100 capsules.
In appearance, the recalled bottles are white and unlabeled, only identified by an Amazon sticker. Because of the missing manufacturer label, the product fails to display the required Over the Counter (OTC) information, drug facts, and information about patient usage. Those in possession of an unlabeled product may misuse the product and are therefore at risk for permanent liver damage in the event that the recommended dose is exceeded, if it is combined with a significant consumption of alcohol, or if the user is allergic to an active ingredient in the product that may be life-threatening.
As of this writing, Aurobindo says it has not been made aware of any adverse reactions or events known to be in connection with the unlabeled medical drug.
Written and phone notification to distributors and customers about the recalled lots, as well the arrangement for the return of the items, is being handled by Qualanex on behalf of Aurobindo Pharma USA, Inc.
Medical questions related to the recall, or reports of any adverse events, may be directed to Aurobindo Pharma USA, Inc. via email at pvg@aurobindousa.com or at 1-86-850-2876, Option 2. Calls are monitored 24 hours a day, 7 days a week.
Those who have experienced a health problem believed to be related to this medical drug should consult their physician.
As the FDA continues to monitor this recall, consumers are encouraged to report any related adverse events to the agency’s MedWatch program.
If you or a loved one has suffered an adverse health outcome that can be attributed to the use of a mislabeled medical drug, your family deserves maximum compensation. Our seasoned attorneys at TruLaw are personally invested in helping people in your situation fight for the best possible outcome. Contact us today or take our free Instant Case Evaluation ℠ to learn more.