Migraine aid recall: Drug sold nationwide through Amazon 'high risk of misuse' due to lack of labeling
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A number of migraine medications shipped by Amazon are being recalled across the country because they lacked the required manufacturer's labels.
Pharmaceutical manufacturer Aurobindo Pharma announced on July 18 that it is 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 notice related to the recall on Wednesday. The refilled bottles contain 100 tablets of 250 mg. each of acetaminophen and aspirin, and 65 mg. of caffeine.
Why was this recall started?
The recall was issued because the manufacturer's lack of labeling created a “significant risk of misuse,” Aurobindo Pharma wrote. The FDA requires all over-the-counter drugs to have manufacturer labels to provide consumers with labeling information, drug facts, and patient use information.
The drug manufacturer wrote that these risks include users taking more of the drug than the recommended dose or drinking too much alcohol while using the drug, which can lead to permanent liver damage. In addition, the drug can be dangerous to the health of users who are allergic to its active ingredient, according to Aurobindo Pharma.
Has anyone been harmed by this product?
Since the July 18 announcement, the drugmaker said it has not received any reports of adverse drug reactions confirmed to be related to the withdrawal.
Where and when was this drug sent?
The recalled batch was first shipped to customers nationwide in January by Amazon after Aurobindo Pharma “inadvertently” provided the distributor with bottles without the manufacturers' labels, the pharmaceutical company wrote.
Aurobindo Pharma did not immediately respond to questions raised Fast company asking why the bottles don't have manufacturers' labels.
After receiving unlabeled bottles, Aurobindo Pharma said Amazon affixed its own sticker with the drug's brand name before continuing to ship the drug to users.
What should I do if I have this product?
The recalled bottles will expire next June and have National Drug Code number 58602-882-21 and lottery number AC2523005A. Aurobindo Pharma described the recalled tablets as “white to off-white” and “capsule-shaped” with “'T' on one side and '57' on the other.”
The recall management company Qualanex will be writing and calling to inform Aurobindo Pharma customers of the recall and inform distributors to “immediately stop” shipping the batch, the drugmaker wrote.
Customers who want to ask medical questions about a recall or report an adverse drug event can call the 24-hour hotline at 866-850-2876 or email pvg@aurobindousa.com. Those with questions about returning a recalled product can contact Qualanex at 888-504-2014.
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