The recall includes three lots of Infants' Ibuprofen Concentrated Oral Suspension that could potentially have higher concentrations of ibuprofen than advertised. 

By Lauren Pardee
PRNewsfoto/Tris Pharma, Inc.

January 31, 2019

In December 2018, Tris Pharma, Inc. voluntarily recalled three lots of Infants' Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL. And now, in the midst of cold and flu season, they’ve doubled their original recall of the same medications. According to a press release, the recalled product could potentially contain higher concentrations of ibuprofen than advertised – as much as 10 percent above the limit, to be exact.  

“There is a remote possibility that infants, who may be more susceptible to a higher potency level of the drug, and therefore may be more vulnerable to permanent NSAID-associated renal injury,” reads a statement from Tris Pharma, Inc. “Adverse effects that may be experienced are nausea, vomiting, epigastric pain, or more rarely, diarrhea. Tinnitus, headache and gastrointestinal bleeding are also possible adverse effects.” 

Equate, CVS Health, and Family Wellness were the three brands distributing the Infants' Ibuprofen Concentrated Oral Suspension—the products were being sold at CVS and Family Dollar (with an expiration date of August 2019 and December 2019), as well as Walmart (with an expiration date of February 2019, April 2019, and August 2019). If you have purchased this medication from any of these providers, either throw the medication away or bring it back to the seller for a full refund. Consumers experiencing medical complications after using this product should see a physician or healthcare provider right away. 

Anyone with further questions regarding the recall can contact Tris Customer Service at 732-940-0358 or email the Customer Service contact: micc_tris@vigilarebp.com. You can also complete and submit a report online at www.fda.gov/medwatch/report.htm.

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