Because infants are at risk for being harmed by higher concentrations of ibuprofen, Tris Pharma has voluntarily initiated a nationwide recall of three lots of Infants’ Ibuprofen Concentrated Oral Suspension, USD (NSAID) 50 mg per 1.25 mL. The recall followed a Health Hazard Evaluation and discussion with the U.S. Food and Drug Administration (FDA).
According to an announcement released by the FDA, the affected lots were packaged in 0.5 ounce bottles and sold to one customer, who then distributed them into the U.S. retail market via Walmart, CVS, and Family Dollar stores. The recalled ibuprofen sold in Walmart stores had expiration dates of February 2019, April 2019 and August 2019; those sold by CVS and Family Dollar stores had expiration dates of August 2019.
Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID) that works by blocking the body’s production of certain natural substances that cause inflammation. Infant ibuprofen is used as a fever reducer and to relieve pain associated with headaches, teething, and minor aches and pains associated with the common cold or flu. Ibuprofen is most effective when used when the first signs of pain or fever occur.
For infants six months of age and older, weight is typically used as a dosage guide when administering ibuprofen, and more than four doses in a 24-hour period is not recommended. The correct dosage and timing are critical for the medication to work well.
Potential Side Effects
Infants given stronger concentrations of ibuprofen could potentially suffer some minor (and major) side effects, such as:
- Tinnitis (ringing in the ears)
- Upper abdominal pain
- Gastrointestinal bleeding
According to a statement released by Tris Pharma on December 5, no serious adverse effects regarding the affected lots have been reported to the company to date.