Infant Ibuprofen Recall 2018
Tris Pharma voluntarily recalled 3 lots of Infant’ Ibuprofen Concentrated Oral Suspension (50mg per 1.25mL) for high concentrations of ibuprofen.
Details of the Infant Ibuprofen Recall
There is a possibility that infants, who are susceptible to a higher potency level of ibuprofen may be more vulnerable to this item. They would experience nausea, vomiting, epigastric pain or more rarely diarrhea. Tinnitus, headache and gastrointestinal bleeding are also possible effects.
There have been no reports of side effects of this product yet.
The Product is used as a pain reliever/fever reduced and was packakged in .5oz bottles. Recalled Lots listed below:
What to Do
Wholesalers and retailers of the product should stop further distribution of the affected lots of Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, which are being recalled.
Consumers with questions regarding this recall can contact Tris Customer Service at 732-940-0358 (Monday through Friday, 8:00am ET- 5:00pm PT) or via email at Customer Service Email . Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
- 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
You can view the full press release from Tris Pharma here
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