Brookstone Pharmaceuticals Concentrated Acetaminophen Drops Recalled Due to Risk of Accidental Overdose
All lots of concentrated acetaminophen drops made by Brookstone Pharmaceuticals, LLC are being recalled today due to concerns about the risks of accidental overdoses in people using the drugs themselves or giving the medication to young children.
The concentrated drops are sold in 16-ounce bulk containers that are generally the same size as containers for regular strength acetaminophen products. Also, the fact that there is no plastic cup or other type of dosage delivery device provided with the containers could lead some users to take too much of the concentrated drops, thinking they are taking regular strength medication rather than a concentrated form, the Food and Drug Administration said.
Brookstone’s concentrated acetaminophen drops contain the drug in levels at 80 mg/0.8 mL, compared to regular strength acetaminophen, which carries the drug in levels at 160 mg/5 mL, the FDA said.
The company has sold 344 of the bottles in the United States and also donated 5,301 bottles to international charities, according to the FDA.
Acetaminophen overdose can cause severe medical problems, including liver toxicity, kidney damage, and various blood disorders. The FDA said it has received several reports of medication errors involving overdoses of concentrated acetaminophen drops in children under age three due to confusion about the proper doses.
However, Brookstone said it has not received any adverse events associated with the recalled acetaminophen products.
Recently, an FDA advisory panel recommended that one of the two strengths of acetaminophen be removed from the market to reduce the chances of such accidental overdoses. The FDA has not yet taken action with regards to that recommendation.
Brookside has stopped manufacturing and shipping its Concentrated Acetaminophen drops in bulk containers and is advising wholesalers, hospitals, and other customers to stop circulating the products immediately. Customers with questions about the acetaminophen drops recall may contact Brookstone at 1-800-541-4802, option 2.
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