Concentrated Acetaminophen Drop Recall: Possible Dosing Errors

More than 5,600 bottles of concentrated acetaminophen drops for infants have been recalled due to risk of overdose, liver injury or death from dosing errors.

The FDA announced this week that Brookstone Pharmaceuticals LLC issued a concentrated acetaminophen infant drop recall for their 16-ounce bulk containers because they do not contain dosing instructions or a dosage delivery system, which could cause an overdose.

The agency indicated that they are aware of several reports of life-threatening or fatal adverse events in children under three years old due to confusion over dosage.

Brookstone’s recalled acetaminophen drops are a generic version of Tylenol’s concentrated drops for infants. They contain 80 mg of acetaminophen per every 0.8 ml. However, there are regular strength drops on the market that contain only 160 mg per 5 ml, which the FDA believes may cause dosage confusion.

Brookstone distributed 344 bottles in the United States, and donated 5,301 bottles to charities for international use.

Receiving too much of the medication could increase the risk of acetaminophen liver damage and other injuries. Recent research has shown that acetaminophen is the leading cause of liver failure in the United States, resulting in 56,000 emergency room visits, 26,000 hospitalizations and over 450 deaths annually between 1990 and 2001. Acetaminophen overdoses can also cause kidney damage and blood disorders.

An FDA Advisory Panel was recently convened to review the safety of acetaminophen and the risk of liver injury caused by receiving too much of the medication. The panel recommended that certain limits be placed on the maximum allowed daily dosage for acetaminophen to reduce the risk of injury, and also also recommended a ban on Percocet and Vicodin, as well as other medications that combine acetaminophen with narcotic painkillers.

The FDA has not yet made a decision on their advisory panel recommendations.