Tris Pharma Inc, a New Jersey-based pharmaceutical company, issued a liquid infant ibuprofen recall due to possible increased levels of the drug, which could cause adverse effects.

The infant ibuprofen recall applies to three batches of Infants' Ibuprofen Concentrated Oral Suspension, USP nonsteroidal anti-inflammatory drugs (NSAID), 50 mg per 1.25 mL, according to a Tris Pharma press release.

The medication is used as a pain reliever and fever reducer for infants ages 6 months to 23 months old. This is being classified as a voluntary recall.

"There is a remote possibility that infants, who may be more susceptible to a higher potency level of drug … may be more vulnerable to permanent NSAID-associated renal injury," states the release.

 

The U.S. Food and Drug Administration knows about the recall, a spokesperson from the FDA confirms to Metro. You can access the same Tris Pharma safety notice on the FDA website

"The decision to initiate this recall of retail inventory was based on a Health Hazard Evaluation followed by discussion with the FDA," reads a separate notice sent to Metro and posted on the Tris Pharma website.

Infant ibuprofen recall: List

Tris Pharma sold the products involved in the infant ibuprofen recall to "one customer, which distributed the lots into the US market. Tris Pharma, Inc. has notified its customer by urgent recall notice and is arranging for the return of the recalled product."

Products were packaged in 0.5 oz bottles and sold in Walmart stores, CVS as well as Family Dollar.

Walmart

Equate ibuprofen packages: national drug code (NDC) 49035-125-23

Lot 00717009A (expiration date 02/19)

Lot 00717015A (expiration date 04/19)

Lot 00717024A (expiration date 08/19)

CVS

CVS Health packages: national drug code (NDC) 59779-925-23

Lot 00717024A (expiration date 08/19)

Family Dollar

Family Wellness packages: national drug code (NDC) 55319-250-23

Lot 00717024A (expiration date 08/19)

Click through the gallery above for product images. 

Tris Pharma says that wholesalers and retailers should stop further distribution of this infant ibuprofen.

What can happen if infants consume too much ibuprofen?

Upon consumption, adverse effects may include nausea, vomiting, diarrhea, gastrointestinal pain, headache, gastrointestinal bleeding, upper abdominal pain and tinnitus ( ringing in the ears).

To date, Tris Pharma says it has not received any reports of "adverse events related to the lots of product that are the subject of this recall."

Questions or concerns about this infant ibuprofen recall? Here's what to do

Tris Pharma says to contact its customer service team at 732-940-0358 or micc_tris@vigilarebp.com.

"Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product," Tris Pharma notes.

You can also report adverse reactions to FDA's MedWatch Adverse Event Reporting program at accessdata.fda.gov

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