The maker of several brands of infant ibuprofen is expanding its voluntary recall, due to concerns that concentrations of the medications may be higher than they should be.

Tris Pharma manufactures the recalled drugs for Walmart, CVS, and Family Dollar stores.

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.

To date, no serious adverse events have been reported related to this recall. The products are packaged in ½ oz. and 1 oz. bottles, and includes the lots listed below:

Equate brand available at Walmart

  • Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 1.0 oz. bottle (Lot: 00717005A, NDC: 49035-125-24, Expires: 02/19)
  • Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle (Lot: 00717009A, NDC: 49035-125-23, Expires: 02/19)
  • Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle (Lot: 00717015A, NDC: 49035-125-23, Expires: 04/19)
  • Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle (Lot: 00717024A, NDC: 49035-125-23, Expires: 08/19)

CVS Health brand available at CVS stores

  • Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 0.5 oz. bottle (Lot: 4718, NDC: 59779-925-23, Expires 12/19)
  • Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 1.0 oz. bottle (Lot: 00717006A, NDC: 59779-925-24, Expires 02/19)
  • Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle (Lot: 00717024A, NDC: 59779-925-23, Expires: 08/19)

Family Wellness brand available at Family Dollar stores

  • Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle (Lot: 00717024A, NDC: 55319-250-23, Expires: 08/19)

If you have questions regarding this recall you can contact Tris Customer Service at 732-940-0358 (Monday through Friday, 7:00 AM to 3:00 PM CT) or via email at micc_tris@vigilarebp.com.

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