Tris Pharma, Inc., has recalled three lots of infant ibuprofen because of a formulation error creating a potency that could cause babies to develop permanent kidney injuries.
Equate, CVS Health and Family Wellness brands involved in recall
The Monmouth Junction, NJ-based company issued the voluntary recall on December 5 because the recalled products may have have higher concentrations of ibuprofen than stated on the packaging.
The company says babies who ingest the recalled product may experience nausea, vomiting, epigastric pain, diarrhea, tinnitus, headaches and gastrointestinal bleeding.
There is also “a remote possibility” that susceptible infants could become vulnerable to permanent NSAID-associated renal injury.
Better to play it safe than sorry on this one, parents! The labels of the affected products look this:
Meanwhile, here the lot numbers, expiration dates and NDC numbers on the affected products:
|Retailer||Product||Lot numbers and expiration dates||NDC|
|Walmart||Equate: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle||
|CVS||CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle||
|Family Dollar||Family Wellness: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle||
If you have any of these in your medicine cabinet at home, please throw it out immediately or return it to the store for a refund.
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