A recall on infant ibuprofen first announced last December has been expanded over concerns it might be too potent. The expanded recall includes Infants Ibuprofen Concentrated Oral Suspension, sold at CVS and Walmart stores under the CVS Health and Equate labels. Both one-ounce and half-ounce bottles are included. The makers say the drug’s concentration could be as much as 10 percent higher than listed and potentially dangerous for babies. No adverse effects have been reported so far.
The voluntarily recall includes the 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.