a New Jersey-based pharmaceutical company is recalling liquid ibuprofen marketed for infants.
Tris Pharma, Inc. is voluntarily recalling three lots of “Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID)” in 50 mg per 1.25 mL. The recall was issued after the company discovered higher concentrations of ibuprofen in the product.
The recalled medication is sold at Walmart, CVS and Family Dollar under store brand names.
The company says that infants may be more susceptible to the higher potency of the drug and therefore may be more vulnerable to permanent NSAID-related renal injury. Effects that could be experienced by infants taking the medication are nausea, vomiting, epigastric pain (pain in ribs or lower abdomen), or diarrhea. Other possible side-effects are Tinnitus, headache or gastrointestinal bleeding.
The company says they have not received any reports of adverse effects related to the recalled product.
Recalled lots include:
- Equate: Infants’ Ibuprofen Concentrated Oral Suspension USP (NSAID), 50 mg per 1.25 mL 0.5 oz bottle sold at Walmart Stores. Lot # 00717009A, 00717015A, 00717024A with expiration dates 02/19, 04/19, 08/19
- CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension USP (NSAID), 50 mg per 1.25 mL 0.5 oz bottle sold at CVS Pharmacy with Lot # 00717024A and expiration date 08/19
- Family Wellness: Infants’ Ibuprofen Concentrated Oral Suspension USP (NSAID), 50 mg per 1.25 mL 0.5 oz bottle sold at Family Dollar stores with the Lot # 00717024A with the expiration date of 08/19.
Consumers should stop the use of the product and alert their child’s healthcare provider if they have experienced any problems with taking the product. Questions can be directed to Tris Customer Service at 732-940-0358.
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