On Tuesday the FDA expanded it’s recall of infants’ oral ibuprofen solution because it may contain higher concentrations of ibuprofen than labeled.
Private brand manufacturer 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 as private brands 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, the manufacturer has not received any reports of adverse effects.
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.
