How FDA drug recalls work
Three more lots of pain and fever baby drops sold at CVS and Walmart have been recalled for having elevated ibuprofen concentration.
Tri Pharma, the manufacturer, added these three lots to the three lots it recalled in November of ibuprofen baby drops sold at CVS, Walmart and Family Dollar. The drops are for kids from 6 months to 23 months.
The drops are sold under CVS’ house brand and the Equate brand, which is sold at Walmart. Tri Pharma previously recalled three lots of CVS, Equate and the Family Wellness brand, made for Family Dollar.
“Infants already susceptible to the adverse effects of ibuprofen may be at a slightly higher risk if they receive medication from an impacted bottle,” the company-written, FDA-posted recall notice says. “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 (Nonsteroidal anti-inflammatory drug-associated) renal injury.”
Tri Pharma says some of the bottles in the recalled lots have ibuprofen up to 10 percent over the limit, but that’s far below the seven times dosage that’s considered unquestionably dangerous for a baby.
All the recalled products are stated to have a concentration of 50 mg per 1.25 ml.
CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension in half-ounce bottles, lot Nos. 4718, expiring 12/2019, and 00717024A, expiring 8/2019. Lot No. 00717006A, expiring 2/2019, came in 1-ounce bottles.
Equate: Infants’ Ibuprofen Concentrated Oral Suspension in 1-ounce bottles, lot No. 00717005A, expiring 2/2019; and, in half-ounce bottles, lot Nos. 00717009A, 00717015A and 00717024A.
Family Wellness: Ibuprofen Oral Suspension Drops in half-ounce bottles, lot No. 00717024A.
Parents or those providing child care with questions can call Tri Pharma at 732-940-0358, Monday through Friday, 8 a.m. to 8 p.m., Eastern time or email email@example.com.