Migraine relief recall: Medicine sold nationwide through Amazon has ‘significant risk of misuse’ due to lack of labels

A batch of over-the counter migraine relief medication that was shipped by Amazon is being recalled nationwide because it was missing the required manufacturer labels.

Pharmaceutical manufacturer Aurobindo Pharma announced on July 18 that it was recalling Healthy Living Migraine Relief, Acetaminophen, Aspirin (NSAID) & Caffeine tablets on behalf of its distribution company Aurohealth. The Food and Drug Administration (FDA) published its associated recall notice on Wednesday. The recalled bottles contain 100 tablets with 250 mg. each of acetaminophen and aspirin, as well as 65 mg. of caffeine.

Why was this recall initiated?

The recall was issued because the batch’s lack of manufacturer labels created a “significant risk of misuse,” Aurobindo Pharma wrote. The FDA requires that all over-the-counter medicines have manufacturer labels to provide consumers with labeling details, drug facts, and patient usage information.

The pharmaceutical manufacturer wrote that these risks included users taking more medicine than the recommended dose or excessively consuming alcohol while using the drug, which could result in permanent liver damage. In addition, the medicine could be life threatening for users who are allergic to its active ingredient, according to Aurobindo Pharma.

Has anyone been injured by this product?

As of the July 18 announcement, the pharmaceutical manufacturer said it had not received any reports of adverse drug events that were confirmed to be related to the recall.

Where and when was this medication shipped?

The recalled batch was first shipped to customers nationwide in January by Amazon after Aurobindo Pharma “inadvertently” supplied the distributor with bottles that were missing manufacturer labels, the pharmaceutical company wrote.

Aurobindo Pharma did not immediately respond to questions from Fast Company asking why the bottles lacked manufacturer labels.

After receiving the unlabeled bottles, Aurobindo Pharma said Amazon put its own sticker containing the medicine’s product name on them before proceeding to ship the medicine to users.

What should I do if I have this product?

The recalled bottles are set to expire next June and have the National Drug Code number 58602-882-21 and lot number AC2523005A. Aurobindo Pharma described the recalled tablets as “white to off-white” and “capsule shaped” with a “‘T’ on one side and ‘57’ on the other side.”

Recall management company Qualanex would be writing and calling to inform Aurobindo Pharma’s customers of the recall and to notify distributors to “immediately discontinue” sending out the batch, the pharmaceutical manufacturer wrote.

Customers looking to ask medical questions about the recall or report an adverse event from the medication can call the 24-hour line 866-850-2876 or email [email protected]. Those with questions about returning the recalled product can contact Qualanex at 888-504-2014.