Alpharetta Georgia based Brookstone Pharmaceuticals is recalling all lots of its Concentrated Acetaminophen Drops. The reason for the recall concerns the way the product is packaged and the absence of an integrated dosage delivery device which may inadvertently cause an overdose. The drug manufacturer's recall comes on the heels of an FDA panel's recommendation to change the way acetaminophen products are consumed and marketed.

Recall details

According to a U.S. Food & Drug Administration (FDA) press release, the company has instituted a nationwide voluntarily recall of all lots of Concentrated Acetaminophen Drops (NDC#42192-504-16) in 16 ounce (473 ml) bulk containers. The 16oz container is comparable to the size generally used to package regular strength acetaminophen liquid preparations. The pharmaceutical company's concentrated acetaminophen contains acetaminophen 80 mg/0.8 ml. Regular strength acetaminophen elixir contains 160 mg/5 ml.

Although no adverse effects have been reported, the company is recalling its product to the consumer level as a cautionary measure to minimize any confusion and potential risk to patients from dosing errors. It says that it has notified customers that it has voluntarily stopped manufacturing and shipping Concentrated Acetaminophen Drops in bulk containers and has also advised customers (wholesalers and hospitals) to quarantine and hold the product for return to Brookstone Pharmaceuticals for a full refund. The company's recall announcement comes only weeks after an FDA panel recommended making changes to acetaminophen usage.

FDA action

An FDA panel has recommended making substantial changes in the way that consumers take acetaminophen (generally known as Tylenol) and how manufacturers market the drug. In a recent meeting in Washington D.C., the panel proposed the following changes:

• Eliminating Vicodin and Percocet
• Lowering the daily maximum dosage of acetaminophen from 4,000 mg to 2,600 mg
• Placing a black box warning on OTC medications containing acetaminophen
• Reducing the single maximum adult dose of acetaminophen to 650 mg, instead of the current 1,000 mg

The FDA panel has made these recommendations because it said that its research showed a strong link between acetaminophen and liver damage. In fact, the panel cited research which showed that between 1990 to 1998, acetaminophen use was responsible for:

• 458 deaths
• 26,000 hospitalizations
• 56,000 emergency room visits

It believes that these numbers are so high because consumers often don't realize the extent to which acetaminophen can damage the liver. Over the counter (OTC) drugs such as cold remedies also generally contain acetaminophen, so consumers may be overdosing on acetaminophen without knowing it. The FDA is likely to rule on the panel's recommendations in the next few months, but Acetaminophen / Tylenol attorneys say that lawsuits against manufactures are ongoing.