FBN's Cheryl Casone on Tris Pharma's recall of liquid ibuprofen for infants.
Company Tris Pharama Inc. released a press release that includes 3 lot numbers of medicine that may contain a higher concentration of the drug that is safe for babies.
The company says there is a remote possibility that infants who may be more susceptible to a higher potency level of drug may also be more vulnerable to permanent NSAID-associated renal injury.
The recalled products sold at Walmart had expiration dates of February 2019, April 2019 and August 2019, while those made for CVS and Family Dollar expire in August 2019.
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The products affected are sold under brand names, "Equate Infants' Ibuprofen Concentrated Oral Suspension", "CVS Health Infants' Ibuprofen Concentrated Oral Suspension", and "Family Wellness Infants' Ibuprofen Concentrated Oral Suspension". "Tinnitus, headache and gastrointestinal bleeding".
Tris Pharma said it has not received any reports of customers experiencing adverse effects from the products.
The recalled product was packaged in 0.5 oz. bottles and labeled "Infants' Ibuprofen Concentrated Oral Suspension" (see product image below).
"This recall is being conducted with the knowledge of the U.S. Food and Drug Administration".
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