Recall: CVS Health, Equate, Family Wellness Ibuprofen Oral Suspension Drops
On 2019-01-29, the FDA announced that Tris Pharma is conducting a recall on Ibuprofen Oral Suspension Drops due to a possible formulation error. The recalled products were sold under the brand name(s) CVS Health, Equate and Family Wellness during an unspecified time period throughout the regions shown in the map below.
In recent months, there have been 2 drugs recalls due to potential formulation error, including infants' ibuprofen concentrated oral suspension, usp (nsaid) 50 mg per 1.25 ml, paliperidone extended-release tablets, 3mg and more. Additionally, there have been 18 drug and medical device recalls due to other health hazards as well as 77 food recalls.
Company Contact Information:
Name: Tris Pharma
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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: Ibuprofen Oral Suspension Drops
Brand Name(s): CVS Health, Equate, Family Wellness
Reason for Recall: Formulation Error
Official Recall Date: 2019-01-29
Additional information provided by the FDA.gov:
Monmouth Junction, NJ, Tris Pharma, Inc. is expanding the scope of its November 2018 recall by adding three (3) 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. 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.