FDA Expands Infant Ibuprofen Recall

The Food and Drug Administration expands its recall of liquid infant ibuprofen.

According to the US Health and Human Services website, Tris Pharma, Inc. is expanding the scope of its November 2018 recall by adding three (3) additional lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, to the retail (pharmacy) level. Some units from these batches have been found to have higher levels of Ibuprofen concentration.

"Infants already susceptible to the adverse effects of ibuprofen may be at a slightly higher risk if they receive medication from an impacted bottle. There is a remote probability that infants, who may be more susceptible to a higher potency level of drug, may be more vulnerable to permanent NSAID-associated renal injury. Some units from these six (6) lots have been found to contain Ibuprofen as high as 10% above the specified limit... To date, no serious adverse events have been reported related to this recall."

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.

The bottles were sold at Wal Mart, CVS, and Family Dollar stores. Anyone who has the recalled meds should throw them away.

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