Your medicine cabinet is probably filled with various painkillers and OTC medicines that are ready when you need them, but there can also be hidden dangers lurking. It is important to check your medicine in the light of new warnings from the US Food and Drug Administration (FDA) about drugs that may put you at risk. In fact, a recent FDA warning cites one of the most common OTC painkillers. Read on to see if you have this medicine in your closet, and if you use this medicine, US officials will have a new warning for you.
The FDA announced on April 2 that AS Medication Solutions, LLM (ASM) is voluntarily recalling nearly 200,000 bottles of Acetaminophen Extra Strength 500 milligram tablets. The medicine recalled comes in 100-liter white plastic bottles and is included in Health Essential Kits distributed to members of Humana, an American medical insurance company. These kits also included one bottle of hand sanitizer, one reusable face mask, one bag of cough drops, one digital thermometer and 50 disposable gloves. And if you take Tylenol with this, your liver is in danger, experts say.
According to the FDA, these bottles are being recalled because it “contains an incomplete label on prescription drugs, rather than the required label for OTC drugs.” The medicine, which was likely to be distributed nationwide between January 14 and March 15, has only a short Rx medicine label on the outside of the bottle, which “lacks the complete OTC medicine facts chart”, according to the recall notice. The FDA says that OTC medicines that comply with the Drug Facts label must contain the following information: the active ingredients of the product, including the quantity in each dosage unit; the purpose of the product; the uses (indications) for the product; specific warnings, including when the product may not be used under any circumstances, and when it is appropriate to consult a doctor or pharmacist; dosing instructions; and the product’s inactive ingredients. And sign up for our daily newsletter for more useful information sent directly to your inbox.
Without proper warning label, this OTC medication can be harmfully abused. For example, if consumers take more than the recommended dose of paracetamol (which should appear on the label), they may be at risk of liver damage. The FDA also notes that consumers should be aware if they are allergic to an active ingredient in this medicine, which is also listed on a complete label. According to the FDA, ASM has not yet received “reports of adverse incidents related to this recall.” And for more FDA warnings: if you have these supplements at home, the FDA says “Destroy them.”
The FDA says that ASM notifies its distributors and customers by mail and arranges for all recalled products to be returned. If you have this product, ASM asks that you “stop using it and return it to pre-addressed return mailers provided by ASM or the distributors.” If you have any questions, please contact ASM Customer Service. If you have any problems with the use of this medicine, you should discuss it with your doctor or healthcare provider. The FDA also requests that any “adverse reactions or quality problems encountered with the use of this product” be reported to the FDA’s MedWatch side-effect reporting program. And if you are taking more OTC medicines than twice a week, visit a doctor.