New Jersey-based Tris Pharma, Inc. said the recalled ibuprofen bears the following lot numbers and National Drug Codes (NDC) on its packaging:
- Walmart – Lot #s 00717009A, 00717015A, 00717024A; NDC 49035-125-23.
- CVS – Lot # 00717024A; NDC 59779-925-23.
- Family Dollar – Lot # 00717024A; NDC 55319-250-23.
These products were labeled to contain 50 mg of Ibuprofen per 1.25 mL. The company said there is a “remote possibility” the increased amount of ibuprofen could lead to permanent kidney injury in infants. Other adverse effects could include:
- Nausea
- Vomiting
- Stomach pain
- Diarrhea
- Tinnitus
- Headaches
- Stomach bleeding
If you have any questions about this recall, you can contact Tris Customer Service at 732-940-0358 (M-F, 8:00am ET- 5:00pm PT) or via email. Adverse reactions or quality problems experienced with the use of product lots subject to this recall may be reported to the FDA’s MedWatch Adverse Event Reporting program.
Source: USA TODAY