Recall of infant Ibuprofen oral suspension drops

Shelly Haberman
Medication recall

In November 2018, three lots of Ibuprofen oral suspension drops, USP, 50 mg/1.25 mL were recalled by the manufacturer, Tris Pharma, Inc.  This infant ibuprofen product was sold at Wal-Mart, CVS and Family Dollar under the names: Equate at Wal-Mart, CVS Health at CVS and Family Wellness at Family Dollar. 

On January 29, 2019, Tris Pharma, Inc. expanded the scope of the November recall to include three additional lots of Ibuprofen oral suspension drops, USP, 50 mg/1.25 mL.  As before, this expanded recall affects only products sold at Wal-Mart, CVS and Family Dollar.

These lots have been subject to recall by Tris Pharma, Inc. because some units from these batches have been found to have higher levels of Ibuprofen concentration, as high as 10 perecent above the specified limit.

Infants already susceptible to the adverse effects of ibuprofen may be at a slightly higher risk if they receive medication from an impacted bottle. To date, Tris Pharma Inc. has announced that no serious adverse events have been reported related to this recall.

It is recommended for consumers who have recently purchased an infant Ibuprofen oral suspension drop product to review the packaging to determine if the product has been recalled. The product is used as a pain reliever/fever reducer and is packaged in ½ oz. and 1 oz. bottles. This voluntarily recall includes the six lots listed below:

LOT #

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
 

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

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

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 Inc

Consumers with questions regarding this recall may contact Tris Customer Service at (732) 940-0358 (Monday through Friday, 8 a.m. ET to 5 p.m. ET) or by e-mail at micc_tris@vigilarebp.com. Consumers, who may be concerned, should contact their physician or health care provider if they have experienced any concerns that may be related to taking or using this drug product.

For more information or to see images of product labels, visit https://www.fda.gov/Safety/Recalls/ucm630112.htm.

Nancy Hyland, PharmD, Regional Director of Community Pharmacy Services, SSM Health

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