Six lots of generic Ibuprofen Oral Suspension Drops for infants manufactured by Tris Pharma Inc., and sold at CVS Pharmacy, Wal-Mart Stores, and Family Dollar are being recalled because some units may contain a higher levels of ibuprofen concentration. Some bottles of the ibuprofen concentrate were found to contain as much as 10 percent above the limit specified on the packaging.
Infants who are already susceptible to ibuprofen side effects may be at a slightly higher risk if they are given a higher concentration of the medication from an affected bottle. For example, these babies may be more vulnerable to permanent NSAID-associated renal injury.
Other adverse events that may be experienced include nausea, vomiting, epigastric pain, and, more rarely, diarrhea. Tinnitus, headache and gastrointestinal bleeding are also possible. To date, Tris Pharma has not received any reports of adverse events related to this issue.
Ibuprofen is a pain reliever and fever reducer. It is packaged in ½-ounce and 1-ounce bottles. A list of affected products and their lot numbers can be found on the company’s news release.
Tris Pharma issued a recall of three lots of Infants’ Ibuprofen Concentrated Oral Suspension on Dec. 5, 2018, due to higher concentrations of ibuprofen. On Jan. 29, Tris expanded the recall to include three more lots.
Tris Pharma has notified wholesalers and retailers about the recall. Consumers who are concerned about adverse events should contact their doctors. Any adverse events related to this recall should be reported to the Food and Drug Administration (FDA) Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Recall Notice