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MONMOUTH JUNCTION, N.J. – Editor’s Note: There was no new expansion of the recall in December 2019, as a previous version of this story suggested. The original expansion of the recall was in January 2019, and the first recall was in November 2018. All six lots affected by the recall have expired, with the latest expiration date being in December 2019. Consumers who previously purchased any of the six lots recalled (listed here) are still welcome to request a refund from Tris Pharma, Inc. The company said there is no deadline to do this, emphasizing that none of the six lots should be consumed due to expiration dates. Tris Pharma, Inc. also said Thursday that none of the six lots were on the shelves since last January’s expansion of the recall. All ibuprofen drops on the market and shelves now are safe and within the recommended dose, the company said.
In January 2019, three ibuprofen oral suspension drops were added to a nationwide retail recall, according to a company announcement posted by the U.S. Food and Drug Administration, and consumers who purchased the drops may still return them to the company for a refund.
Tris Pharma, Inc., headquartered in Monmouth Junction, New Jersey, announced last January that it had expanded 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 the six batches were found to have higher levels of ibuprofen concentration, the company announced.
Tris Pharma, Inc., headquartered in Monmouth Junction, New Jersey, announced in January 2019 that it 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
There has been no update or expansion to the company’s recall since January of 2019, according to company officials and the FDA.
“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 (Nonsteroidal anti-inflammatory drugs)-associated renal injury,” the announcement said last January.
Some units from the six lots were found to contain ibuprofen as high as 10% above the specified limit, according to the company. Studies have shown that safety issues or toxicity are generally accepted to be a concern in infants at doses in excess of 700% of the recommended dose.
As of January 2019, no serious adverse events had been reported related to the recall, the announcement said last year.
The product is used as a pain reliever/fever reducer and is packaged in 0.5 oz. and 1 oz. bottles.
Tris Pharma, Inc. said it had notified its customers by urgent recall notice and has arranged for the return of recalled products from retailers and distributors in January 2019.
“Consumers, who may be concerned, should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product,” the announcement said.
Consumers who still own any of the six lots listed can still request a refund.