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Tris Pharma Voluntary Recall: Infants’ Ibuprofen

December 6, 2018, 9:46 AM HST · Updated December 6, 9:46 AM
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PC: FDA

Tris Pharma, Inc. has voluntarily recalled three lots of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, to the retail level. The recalled lots of the product have been found to potentially have higher concentrations of ibuprofen.

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, which has been distributed to Wal-Mart Stores, CVS Pharmacy and Family Dollar Services.

According to the recall information, 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.

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;
49035-125-2300717009A
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
59779-925-2300717024A08/19CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension,
USP (NSAID), 50 mg per 1.25 mL,
0.5 oz. bottle
CVS Pharmacy
55319-250-2300717024A08/19Family Wellness: Infants’ Ibuprofen Concentrated Oral Suspension,
USP (NSAID), 50 mg per 1.25 mL,
0.5 oz. bottle
Family Dollar Services Inc.
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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.

Consumers with questions regarding this recall can contact Tris Customer Service at 732-940-0358 (Monday through Friday, 8 a.m. ET- 5 p.m. PT) or via email at Customer Service Email . Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

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Adverse reactions or quality problems associated with the use of this product may be reported to FDA’s MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax.

This recall is being conducted with the knowledge of the US Food and Drug Administration.

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