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Infant Ibuprofen recall
ILLINOIS — A New Jersey-based company this week issued a nationwide recall of liquid medicine used as an infant pain reliever and fever reducer and sold at Walmart, CVS and Family Dollar. Tris Pharma has voluntarily recalled three lots of Infants’ Ibuprofen Concentrated Oral Suspension sold under the brands Equate (Walmart), Family Wellness (Family Dollar) and CVS Health because of potentially high levels of concentrations of the drug.
In a press release, company said there is a remote possibility that infants may be more susceptible to a higher potency level of drug, and therefore may be more vulnerable to permanent 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, according to the release.
The following .5-ounce bottles have been recalled:
Equate: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle
CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle
Family Wellness: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle
To date, Tris Pharma says it has not received any reports of adverse events related to the product that are the subject of this recall.
Tris Pharma said it sold the affected product to one customer. The company said it notified the customer by “urgent recall notice” and is arranging for the return of the recalled product.
Consumers with questions regarding this recall can contact Tris Customer Service at 732-940-0358 (Monday through Friday, 8 a.m. ET through 5 p.m. PT) or via email at email@example.com.
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.
Adverse reactions or other problems experienced with the use of the product lots subject to this recall may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax: Download the form from www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178