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Wholesalers and retailers of the product should stop further distribution of the affected lots of Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, which are being recalled.Ĭonsumers with questions regarding this recall can contact Tris Customer Service at 732.940.0358 (Monday through Friday, 8:00am ET- 5:00pm PT) or via email at Customer Service Email. has notified its customer by urgent recall notice and is arranging for the return of the recalled product. sold the affected lots of Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL to one customer, which distributed the lots into the US market. The product is used as a pain reliever/fever reducer and is packaged in ½ oz. To date, no serious adverse events have been reported related to this recall. Studies have shown that safety issues or toxicity is generally accepted to be a concern in infants at doses in excess of 700 percent of the recommended dose. Some units from these six (6) lots have been found to contain Ibuprofen as high as 10 percent above the specified limit. There is a 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. Infants already susceptible to the adverse effects of ibuprofen may be at a slightly higher risk if they receive medication from an impacted bottle. Some units from these batches have been found to have higher levels of Ibuprofen concentration. Voluntary recall: Select lot numbers of Infant Ibuprofen Concentrated Oral Suspension sold at Walmart, CVS and Family Dollar:Ĭomplete information including affected lot numbers and images of the product labels are available at here.Īs reported on the FDA website, on JanuTris Pharma is expanding the scope of its November 2018 recall by adding three (3) additional lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, to the retail (pharmacy) level.
