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 firstname.lastname@example.org.
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