Infant Ibuprofen Recall Expanded

According to Newsweek, in addition to the children's ibuprofen recall that was initially announced in December, three more batches of infant liquid ibuprofen have been included in a voluntary recall because of concerns that there are higher levels of concentration for the medicine.

In a news release, Tris Pharma, Inc. said Infants’ Ibuprofen Concentrated Oral Suspension, is a pain reliever and fever reducer and sold in half-ounce and 1-ounce bottles at CVS Pharmacy and Walmart stores across the United States.  The three lots (or batches) labeled 4718, 00717005A and 00717006A, were added to the three products (00717009A; 00717015A; 00717024A) whose recall was announced in December 2018. Some units from those six lots contain Ibuprofen concentrations high as 10 percent above the specified limit, according to manufacturer Tris Pharma.

Studies have shown that safety issues or toxicity is generally accepted to be a concern in infants at doses in excess of 700 percent of the recommended dose.1 To date, no serious adverse events have been reported related to this recall

FDA Release

The following is a list of the three additional batches added to the recall, followed by the original products recalled.

• CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 0.5 oz. bottle, sold by CVS Pharmacy, lot 4718, (expiration 12/19), NDC: 59779-925-23.
• Equate: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 1.0 oz. bottle, sold by Walmart, lot 00717005A (expiration 2/19), NDC: 49035-125-24.
• CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 1.0 oz. bottle, sold by CVS Pharmacy, lot 00717006A (expiration 2/19), NDC: ,59779-925-24 (Labeled as 50428-1252-4).

Previous Recalls:

• Equate: Infants' Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle; sold by Walmart; lots 00717009A (expiration 02/19), 00717015A (expiration 04/19) and 00717024A (expiration 08/19); NDC: 49035-125-23;
• CVS Health: Infants' Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle; sold by CVS Pharmacy; lot 00717024A (expiration 08/19); NDC: 59779-925-23;
• Family Wellness: Infants' Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle; sold by Family Dollar; lot 00717024A (expiration 08/19); NDC: 55319-250-23.

If you have any questions, Tris Pharma’s customer service line can be reached at (732) 940-0358 from 8 am to 5 pm,  Monday through Friday or via email micc_tris@vigilarebp.com.