{"id":1645,"date":"2019-01-29T22:58:39","date_gmt":"2019-01-29T22:58:39","guid":{"rendered":"https:\/\/tris.sambrownprojects.com\/tris-pharma-inc-expands-its-voluntary-nationwide-retail-recall-of-ibuprofen-oral-suspension-drops-usp-50-mg-per-1-25-ml-due-to-higher-concentration-of-ibuprofen\/"},"modified":"2023-08-23T15:25:06","modified_gmt":"2023-08-23T14:25:06","slug":"tris-pharma-inc-expands-its-voluntary-nationwide-retail-recall-of-ibuprofen-oral-suspension-drops-usp-50-mg-per-1-25-ml-due-to-higher-concentration-of-ibuprofen","status":"publish","type":"post","link":"https:\/\/www.trispharma.com\/tris-pharma-inc-expands-its-voluntary-nationwide-retail-recall-of-ibuprofen-oral-suspension-drops-usp-50-mg-per-1-25-ml-due-to-higher-concentration-of-ibuprofen\/","title":{"rendered":"Tris Pharma, Inc Expands Its Voluntary Nationwide Retail Recall of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, Due to Higher Concentration of Ibuprofen"},"content":{"rendered":"
Published on January 29, 2019
\nCONTACT INFORMATION
\nTris Pharma, Inc.
\nTris Customer Service
\n(732) 940-0358<\/p>\n
FOR IMMEDIATE RELEASE \u2013 January 29, 2019 \u2013 Monmouth Junction, NJ, Tris Pharma, Inc.<\/strong> 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<\/strong>, to the retail (pharmacy) level. Some units from these batches have been found to have higher levels of Ibuprofen concentration.<\/p>\n Infants already susceptible to the adverse effects of ibuprofen may be at a slightly higher risk if they receive medication from an impacted bottle. 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. Some units from these six (6) lots have been found to contain Ibuprofen as high as 10% above the specified limit. Studies have shown that safety issues or toxicity is generally accepted to be a concern in infants at doses in excess of 700% of the recommended dose.1<\/sup> To date, no serious adverse events have been reported related to this recall.<\/p>\n The product is used as a pain reliever\/fever reducer and is packaged in \u00bd oz. and 1 oz. bottles. This voluntarily recall includes the six (6) lots listed below:<\/p>\n