(WTNH) — New Jersey-based pharmaceutical company, Tris Pharma Inc., has expanded its voluntary recall of its infants’ liquid ibuprofen after discovering higher concentrations of the medication in some packages.
The company added three additional lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, to the retail (pharmacy) level.
The FDA reports infants already susceptible to the adverse effects of ibuprofen may be slightly higher at risk if they receive medication from an impacted bottle.
There is also the remote probability that infants, who may be more susceptible to a higher potency level of drug, may be more vulnerable to permanent NSAID-associated renal injury.
Altogether, the company has recalled six lots of the medicine and found that they contained 10% more ibuprofen than the specified limit.
The impacted items were sold at Walmart, CVS, and Family Dollar.
The products should not be used but thrown out or brought to the store where it was purchased from for a full refund.
Consumers with questions regarding the recall may contact Tris Customer Service by (732) 940-0358 or via email at micc_tris@vigilarebp.com.