Tris Pharma expands its voluntary nationwide recall of Ibuprofen Oral Suspension Drops

(FDA) — Tris Pharma, Inc. is expanding the scope of its November 2018 recall by adding three additional lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, to the retail pharmacy level. Some units from these batches have been found to have higher levels of Ibuprofen concentration.

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. Some units from these six lots have been found to contain Ibuprofen as high as 10% above the specified limit. Studies have shown that safety issues or toxicity is generally accepted to be a concern in infants at doses in excess of 700% of the recommended dose.1 To date, no serious adverse events have been reported related to this recall.

The product is used as a pain reliever/fever reducer and is packaged in ½ oz. and 1 oz. bottles. This voluntarily recall includes the six (6) lots listed below:

• CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mh per 1.25 mL, in 0.5 oz. bottle, lot number-4718, expiration date 12/19
• Equate: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, 1.0 oz. bottle, lot number 00717005A, expiration date 2/19
• CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 1.0 oz. bottle, lot number 59779-925-24, expiration date 2/19

Tris Pharma, Inc. manufactures Ibuprofen Oral Suspension Drops, USP for a single customer, who markets and distributes the product to retailers. The retailers should stop further distribution of the affected lots, which are being recalled. Tris Pharma, Inc. has notified its customer by urgent recall notice and has arranged for the return of recalled products from retailers and distributors.