{"id":1647,"date":"2018-12-05T22:58:39","date_gmt":"2018-12-05T22:58:39","guid":{"rendered":"https:\/\/tris.sambrownprojects.com\/tris-pharma-issues-voluntary-nationwide-recall-of-infants-ibuprofen-concentrated-oral-suspension-usp-nsaid-50-mg-per-1-25-ml-due-to-potential-higher-concentrations-of-ibuprofen\/"},"modified":"2024-06-03T11:14:11","modified_gmt":"2024-06-03T10:14:11","slug":"tris-pharma-issues-voluntary-nationwide-recall-of-infants-ibuprofen-concentrated-oral-suspension-usp-nsaid-50-mg-per-1-25-ml-due-to-potential-higher-concentrations-of-ibuprofen","status":"publish","type":"post","link":"https:\/\/www.trispharma.com\/tris-pharma-issues-voluntary-nationwide-recall-of-infants-ibuprofen-concentrated-oral-suspension-usp-nsaid-50-mg-per-1-25-ml-due-to-potential-higher-concentrations-of-ibuprofen\/","title":{"rendered":"Tris Pharma Issues Voluntary Nationwide Recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, Due to Potential Higher Concentrations of Ibuprofen"},"content":{"rendered":"

Published on December 06, 2018<\/p>\n

MONMOUTH JUNCTION, NJ, December 05, 2018 \/ PRNewswire\/ -\u2013 Monmouth Junction, NJ, Tris Pharma, Inc. has voluntarily recalled three (3) lots of Infants\u2019 Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, to the retail level. The recalled lots of the product have been found to potentially have higher concentrations of ibuprofen.<\/p>\n

There is a remote possibility that infants, who may be more susceptible to a higher potency level of drug, and therefore may be more vulnerable to permanent NSAID-associated renal injury. Adverse effects that may be experienced are nausea, vomiting, epigastric pain, or more rarely, diarrhea. Tinnitus, headache and gastrointestinal bleeding are also possible adverse effects. To date, Tris Pharma, Inc. has not received any reports of adverse events related to the lots of product that are the subject of this recall.<\/p>\n

The product is used as a pain reliever\/fever reducer and was packaged in 0.5 oz. bottles for the recalled lots listed below:<\/p>\n\n\n\n\n\n\n\n
NDC<\/b><\/td>\nLOT<\/b><\/td>\nEXPIRATION<\/b><\/b><\/td>\n\u00a0 \u00a0 \u00a0 DESCRIPTION<\/b><\/td>\nCOMPANY<\/b><\/td>\n<\/tr>\n<\/thead>\n
49035-125-23<\/td>\n00717009A<\/p>\n

00717015A<\/p>\n

00717024A<\/td>\n

02\/19<\/p>\n

04\/19<\/p>\n

08\/19<\/td>\n

Equate: Infants\u2019 Ibuprofen Concentrated Oral Suspension,<\/p>\n

USP (NSAID), 50 mg per 1.25 mL,<\/p>\n

0.5 oz. bottle<\/td>\n

Wal-Mart Stores Inc<\/td>\n<\/tr>\n
59779-925-23<\/td>\n00717024A<\/td>\n08\/19<\/td>\nCVS Health: Infants\u2019 Ibuprofen Concentrated Oral Suspension,<\/p>\n

USP (NSAID), 50 mg per 1.25 mL,<\/p>\n

0.5 oz. bottle<\/td>\n

CVS Pharmacy<\/td>\n<\/tr>\n
55319-250-23<\/td>\n00717024A<\/td>\n08\/19<\/td>\nFamily Wellness: Infants\u2019 Ibuprofen Concentrated Oral Suspension,<\/p>\n

USP (NSAID), 50 mg per 1.25 mL,<\/p>\n

0.5 oz. bottle<\/td>\n

Family Dollar Services Inc.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Tris Pharma, Inc. 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. Tris Pharma, Inc. has notified its customer by urgent recall notice and is arranging for the return of the recalled product.<\/p>\n

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.<\/p>\n

Consumers 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\u00a0Customer Service Email<\/a>\u00a0. \u00a0Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.<\/p>\n

Adverse reactions or quality problems experienced with the use of the product lots subject to this recall may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.<\/p>\n