Walmart, CVS, Family Dollar Recall Infant Ibuprofen

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.

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Christopher Durham
Christopher Durham is the president of My Private Brand and the co-founder of The Vertex Awards. He is a strategist, author, consultant and retailer who built brands at Delhaize-owned Food Lion, and lead strategy and brand development for Lowe’s Home Improvement. He has consulted with retailers around the world on their private brand portfolios including: Family Dollar, Petco, Staples, Office Depot, Best Buy, Metro (Canada), TLW (Taiwan) and Hola (Taiwan). Durham has published five definitive books on private brands, including his first book, Fifty2: The My Private Brand Project. In 2017, he will debut his newest book, Vanguard: Vintage Originals, a visual tour of innovation and disruption in private brand going back to the mid-1800’s. Dynamic in his presentation while down to earth and frank in his opinions, he has presented at numerous conferences, including FUSE, The Dieline Conference, Packaging that Sells, Omnishopper and PLMA’a annual trade show in Chicago. Durham lives in Charlotte, NC with his wife, Laraine, and two daughters, Olivia and Sarah.