If you have a sick baby at home and recently purchased infant liquid Ibuprofen from CVS, Walmart or Family Dollar, listen up. Tris Pharma, Inc. has voluntarily recalled three lots of their Infants’ Ibuprofen Concentrated Oral Suspension USP (NSAID) 50 mg per 1.25 mL after finding the recalled medication has potentially higher concentrations of ibuprofen than stated on the label.
There have been no reports of adverse reactions related to the recalled product. However, Tris Pharma, Inc. says there is a small chance that infants who are susceptible to a higher potency level of ibuprofen may be vulnerable to permanent kidney damage.
If your child does experience side effects from the drug, they may include nausea, vomiting, pain high in the stomach right below the chest and, rarely, diarrhea. Ringing in the ears, headache and gastrointestinal bleeding are also possible.
To date, Tris Pharma, Inc. says it has not received any reports of adverse events related to the recalled lots of this specific product.
The pharmaceutical company sold the batch of higher-potency ibuprofen to a customer who distributes the medication to stores in the U.S. According to a release about the recall, Tris Pharma, Inc. has notified that customer and is arranging for the recalled product to be returned.
The recalled products are meant for children 6-23 months old. It was sold to U.S. customers in 0.5-ounce bottles at CVS, Walmart and Family Dollar under the brand names CVS Ibuprofen, Family Wellness Infants’ Ibuprofen and Equate Infants’ Ibuprofen.
To check your ibuprofen to see if an item you bought has been recalled, look for the following information on the packaging:
- CVS: Lot number 00717024A, with an expiration date of August 2019.
- Family Wellness, sold at Family Dollar: Lot number 00717024A, with an expiration date of August 2019.
- Equate, sold at Walmart: Lot number 00717009A and an expiration date of February 2019; 00717015A with an expiration date of April 2019; and 00717024A with an expiration date of August 2019.
Consumers with questions regarding this recall can contact Tris Customer Service at 732-940-0358 or via email at their customer service email address, [email protected] Parents should also contact their physician or healthcare provider if their children have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality 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.