The affected lots have been found to contain levels of ibuprofen concentration that are higher than the specified limit.
A nationwide recall of Tris Pharma’s Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL has been expanded to include an additional 3 lots. The affected lots have been found to contain levels of ibuprofen concentration that are higher than the specified limit.
Six lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL products are now included in the recall. Some units from the recalled 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.
The product is used as a pain reliever and fever reducer and is packaged in ½ oz. and 1 oz. bottles.
Infants already susceptible to the adverse effects of ibuprofen may be at a slightly higher risk if they receive medication from an impacted bottle, according to the FDA. There also 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.
No serious adverse events have been reported related to this recall, according to the FDA announcement.
The affected lots can be found on the FDA website.
Consumers with questions regarding this recall may contact Tris Customer Service by calling 1-732-940-0358 or via email at email@example.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 [news release]. Silver Spring, MD; January 29, 2019: FDA website. http://www.pharmacytimes.com/link/250. Accessed January 30, 2019.