Infant liquid ibuprofen recalled over safety concerns, sold at Walmart, CVS, Family Dollar

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Infant liquid ibuprofen recalled over safety concerns. Tamala Edwards reports during Action News Mornings on January 31, 2019. (FDA.gov)

The FDA issued an expanded recall of infants' oral ibuprofen solution because it may have potentially higher concentrations of ibuprofen than labeled.

Tris Pharma, Inc., initially recalled the drug in November 2018. The FDA said the company's Infants' Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, were sold at Walmart, CVS and Family Dollar.

Adverse effects that could be experienced include nausea, vomiting, epigastric pain, or more rarely diarrhea. Tinnitus, headache and gastrointestinal bleeding are also possible adverse effects. So far, Tris Pharma has not received any reports of adverse effects.

The product is used as a pain reliever/fever reducer and is packaged in oz. and 1 oz. bottles. The voluntarily recall includes the six lots listed below:

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

Lot No. 00717005A
NDC: 49035-125-24
EXPIRATION: 02/19
DESCRIPTION: Equate: Infants' Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 1.0 oz. bottle
Company: Wal-Mart Stores Inc.
Lot No. 00717006A
NDC: 59779-925-24 (Labeled as: 50428-1252-4)
EXPIRATION: 02/19
DESCRIPTION: CVS Health: Infants' Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 1.0 oz. bottle
Company: CVS Pharmacy

Lot No. 00717009A (Previously announced)
NDC: 49035-125-23
EXPIRATION: 02/19
DESCRIPTION: Equate: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle
Company: Wal-Mart Stores Inc

Lot No. 00717015A (Previously announced)
NDC: 49035-125-23
EXPIRATION: 04/19
DESCRIPTION: Equate: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle
Company: Wal-Mart Stores Inc

Lot No. 00717024A (Previously announced)
NDC: 49035-125-23
EXPIRATION: 08/19
DESCRIPTION: Equate: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle
Company: Wal-Mart Stores Inc

NDC: 59779-925-23
EXPIRATION: 08/19
DESCRIPTION: Equate: CVS Health: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle
Company: CVS Pharmacy

NDC: 55319-250-23
EXPIRATION: 08/19
DESCRIPTION: Family Wellness: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle
Company: Family Dollar Services Inc.

Stores have been asked to return any of the affected product they have. If you have any of the recalled medications, throw them away.

Consumers with questions regarding this recall may contact Tris Customer Service by 732-940-0358.

Click here for the full FDA recall notice.
Related Topics:
healthconsumerrecallibuprofenchildrenu.s. & world
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