A New Jersey pharmaceutical manufacturer is recalling some infants' Ibuprofen sold at Walmart, CVS and Family Dollar Stores over concerns that the medicine may be too potent.
Tris Pharma, Inc. has voluntarily recalled three lots of Infants' Ibuprofen Concentrated Oral Suspension, 50 mg per 1.25 mL. The recalled medicine has been found to potentially have higher concentrations of ibuprofen.
The company says there is a remote possibility that infants who may be more susceptible to a higher potency level of drug may also be more vulnerable to permanent NSAID-associated renal injury.
Adverse effects that may be experienced are nausea, vomiting, epigastric pain, or more rarely, diarrhea. Tinnitus, headache and gastrointestinal bleeding are also possible adverse effects.
The company says that as of Wednesday it has not received any reports of adverse events related to the lots of product being recalled.
The product is used as a pain reliever/fever reducer and was packaged in 0.5 oz. bottles for the recalled lots listed below:
The company says wholesalers and retailers of the product should stop further distribution of the recalled products.
People with questions about the recall can contact Tris Customer Service at 732-940-0358 (Monday through Friday, 8:00 am ET- 5:00 pm PT) or via email at customer service email.
You should contact your physician or healthcare provider if you have experienced any problems that may be related to taking or using the drug.
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.
Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form 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
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.