Infant Ibuprofen Is Being Recalled

According to the U.S. Food and Drug Administration website, Tris Pharma Inc., based in Mammoth Junction New Jersey, is expanding their recall of ibuprofen oral suspension drops, USP, 50 mg per 1.25 mL.

Some of the units were found to contain higher levels of ibuprofen concentration. Some contained more than 10% above the specified limit.

The original recall started in November of 2018 and was just expanded on January 29th of this year. They are worried that some of the infants may be vulnerable to permanent NSAID - Associated renal injury.

The brands affected include CVS Health Infants Ibuprofen and Equate Infants Ibuprofen which is sold at Walmart stores.

According to the US Food and Drug Administration website, the voluntary recall includes the six items listed below.

ot No. NDC EXPIRATION DESCRIPTION COMPANY
4718 59779-925-23 12/19 CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 0.5 oz. bottle CVS Pharmacy

00717005A 49035-125-24 02/19 Equate: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 1.0 oz. bottle Wal-Mart Stores Inc.

00717006A 59779-925-24 (Labeled as: 50428-1252-4) 02/19 CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 1.0 oz. bottle CVS Pharmacy

00717009A(Previously announced) 49035-125-23 02/19 Equate: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle Wal-Mart Stores Inc

00717015A(Previously announced) 49035-125-23 04/19 Equate: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle Wal-Mart Stores Inc

00717024A(Previously announced) 49035-125-23 08/19 Equate: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle Wal-Mart Stores Inc

59779-925-23 CVS Health: Ibuprofen Oral Suspension Drops,USP, 50 mg per 1.25 ml, in 0.5 oz. bottle CVS Pharmacy

55319-250-23 Family Wellness: Ibuprofen Oral Suspension Drops,USP, 50 mg per 1.25 ml, in 0.5 oz. bottle Family Dollar Services

If you purchased any of these products you should return them to the point of purchase.

[via Food and Drug Administration/UpToDate]