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Home > Recalled Products > Drugs > Formulation Error > Family Wellness Infants' Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 Mg Per 1.25 ML

Recall: Family Wellness Infants' Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 Mg Per 1.25 ML

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On 2018-12-05, the FDA announced that Tris Pharma is conducting a recall on Infants' Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 Mg Per 1.25 ML due to a possible formulation error. The recalled products were sold under the brand name(s) Family Wellness during an unspecified time period throughout the regions shown in the map below.

In recent months, there have been 1 drugs recalls due to potential formulation error, including paliperidone extended-release tablets, 3mg, hyoscyamine sulfate 0.125 mg tablets and more. Additionally, there have been 19 drug and medical device recalls due to other health hazards as well as 88 food recalls.

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Family Wellness: Infants’ Ibuprofen Concentrated Oral Suspension, Berry Flavor 0.5 oz. bottle
Note: Images may not be available for every version. Please review the detailed description below.

Company Contact Information:

Name: Tris Pharma
Website: http://www.trispharma.com/
Phone: 732-940-0358

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Detailed Recall Information



Regions Where Sold: Because the region was not specified, it is assumed that this product was available nationwide.

Product Description: Infants' Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL

Brand Name(s): Family Wellness

Reason for Recall: Formulation Error

Official Recall Date: 2018-12-05


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Additional information provided by the FDA.gov:

Pharma, Inc. has voluntarily recalled three (3) 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. Read More.


More information may be available at FDA.gov
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Sources may include Food & Drug Administration (FDA), United States Department of Agriculture (USDA), Health Canada and companies involved with this or a related recall.

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