Infant ibuprofen voluntary recall expanded to 3 more products

Three more lots of infant liquid ibuprofen have been included in a voluntary recall because of concerns there are higher levels of concentration for the medicine, Newsweek reported Thursday.

In a news release, Tris Pharma, Inc., of Monmouth Junction, New Jersey, said Infants' Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, 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, 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 concentrationas high as 10 percent above the specified limit, Tris Pharma said in its news release.

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According to a news release by the Food and Drug Administration, "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."

The recall by Tris Pharma includes the following products:

• 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).

Here are the 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.

Customers with questions can call Tris Pharma’s customer service line at 732-940-0358 from 8 a.m. EST to 5 p.m. PST Monday through Friday or send an email to micc_tris@vigilarebp.com.

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