Recall Expanded for Oral Suspension Drops – APhA submits compounding comments to FDA. – (866) 348-2889.
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.