Overdose Concerns Spark Recall of Infant Ibuprofen from Numerous Retailers

Infant ibuprofen manufactured by Tris Pharma was recalled because of concerns over concentrations potentially being too high. The recalled batches of the medication were sold at Family Dollar, Walmart, and CVS.

In total, three lots are impacted by the recall. The announcement of the recall states that the Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL could be dangerous because the concentration of the active ingredient, ibuprofen, could be too high.

The medication is sold over the counter and comes in a liquid form. This drug is intended for use in children between the ages of 6 months and 23 months and is used to reduce fevers and relieve pain.

The manufacturer claims that it has not received any reports of adverse events in relation to the recalled medication. There is a possibility of a patient suffering from a variety of symptoms as a result of the improper concentration, including “nausea, vomiting, upper abdominal pain, diarrhea, gastrointestinal pain, ringing in the ears and headache.”

In some infants, there is a small chance of more serious complications from the highly potent drug, such as permanent renal injuries.

The Ibuprofen was sold as .5-ounce bottles under various brand names. At Walmart, the medication was sold as Equate ibuprofen, and the impacted packages expire in February 2019, April 2019, or August 2019. The CVS brand expires in August of 2019. At the Family Dollar, the medication was sold under the label Family Wellness, and it expires in August of 2019.

Anyone who purchased this medication is being instructed not to use it, and to either return it or discard it and retails carrying the product should discontinue selling the recalled batches.

Drug recalls occur whenever a medication is found to be dangerous or defective. In many cases, a manufacturer will find that there is a problem with the medication and make the decision to recall the drug from the market. Medications can be defective because a problem was discovered with previously unknown risks inherent to the medication, or because something went wrong during the manufacturing process making an otherwise safe medication dangerous. Medications can become contaminated during the manufacturing process, or they can be mixed with the wrong concentration or proportions of ingredients.

The Food and Drug Administration (FDA) oversees medications that are sold in the United States. The FDA has the ability to request that a company issue a recall. While most companies make the voluntary choice to issue recalls, the FDA can push the issue if a company is unwilling to take the necessary steps to keep the public safe. The FDA can also determine whether the recall that a company issues is adequate given the situation.

The FDA also classifies recalls based on how severe they and how much they put people at risk. A Class I recall is considered a highly serious situation where a product can cause “serious health problems or death.” In a Class II recall, the defective product can “cause a temporary health problem or pose slight threat of a serious nature.” Class III recalls are typically issued if the FDA believes that the labeling on a product is not in compliance with the law, or if the manufacturing laws were violated.

In most cases, if a product is recalled, the consumer can recover a refund from the retailer or the manufacturer.