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news.Tris Pharma has voluntarily recalled three lots of Infants' Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, to the retail level in the US.
Image: Recalled infants' liquid Ibuprofen product of Tris Pharma. Photo: courtesy of PRNewsfoto/Tris Pharma, Inc.
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The recalled lots of the product have been found to potentially have higher concentrations of ibuprofen.
There is a remote possibility that infants, who may be more susceptible to a higher potency level of drug, and therefore may be more vulnerable to permanent NSAID-associated renal injury.
Adverse effects that may be experienced are nausea, vomiting, epigastric pain, or more rarely, diarrhea. Tinnitus, headache and gastrointestinal bleeding are also possible adverse effects. To date, Tris Pharma, Inc. has not received any reports of adverse events related to the lots of product that are the subject of this recall.
The product is used as a pain reliever/fever reducer and was packaged in 0.5 oz. bottles for the recalled lots listed below:
|
NDC |
LOT |
EXPIRATION |
DESCRIPTION |
COMPANY |
|
49035-125-23 |
00717009A 00717015A 00717024A |
02/19 04/19 08/19 |
Equate: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle |
Wal-Mart Stores Inc |
|
59779-925-23 |
00717024A |
08/19 |
CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle |
CVS Pharmacy |
|
55319-250-23 |
00717024A |
08/19 |
Family Wellness: Infants’ Ibuprofen Concentrated Oral  Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle |
Family Dollar Services Inc. |
Tris Pharma, Inc. sold the affected lots of Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL to one customer, which distributed the lots into the US market.
Tris Pharma, Inc. has notified its customer by urgent recall notice and is arranging for the return of the recalled product.
Wholesalers and retailers of the product should stop further distribution of the affected lots of Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, which are being recalled.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Source: Company Press Release
