Three lots of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, are being recalled by Tris Pharma.
These lots had potentially higher concentrations of ibuprofen in the bottles.
It is possible that infants, who are more susceptible to slight variations in potency, may suffer adverse side effects if the medication is a higher concentration than listed.
Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID), used commonly for pain relief. It works by blocking your body’s production of substances that cause inflammation. This effect helps to decrease swelling, pain, or fever.
Possible side effects from an incorrect dose of ibuprofen may include permanent NSAID-associated renal injury.
Infants taking ibuprofen can suffer serious bleeding as a side effect- usually gastrointestinal bleeding, commonly in the stomach but possibly anywhere along the gastrointestinal tract. Bloody vomit, a stomachache that doesn’t go away, and feeling faint are indicators of stomach bleeding.
Other possible side effects are liver problems like jaundice and hepatitis. As many as 15 percent of infants taking ibuprofen showed elevated liver function.
When giving a child ibuprofen, keep an eye out for nausea, vomiting, epigastric pain,and, more rarely, diarrhea.
Tris Pharma, Inc., sold the affected lots to only one customer, who distributed the ibuprofen to Family Wellness, CVS, and Equate, among others. Tris Pharma, Inc. has urgently notified this customer and is arranging the return of all affected products.
To date, Tris Pharma, Inc. hasn’t received any reports of adverse side effects related to the lots they are recalling.
The affected lots are listed on the FDA website.
Tris Pharma is a fully integrated pharmaceutical company focused on the development of innovative medicines that address unmet patient needs. Using its proprietary technology platform, LiquiXR®, Tris has pioneered the delivery of sustained release in the liquid, chewable, orally disintegrating tablet, and other dosage forms that benefits a wide variety of patients and their unique needs. Tris’ Nobuse™ technology provides abuse deterrence for opioids and other abuse-prone drugs. Tris’ research, manufacturing and commercial facilities are located in Central New Jersey. For more information, please visit their website. .
Consumers with questions regarding this ibuprofen 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 .
Adverse reactions or quality problems associated with the use of this product should be reported to a physician or hospital. After that, they should be reported to FDA’s MedWatch Adverse Event Reporting program either by phone, on line, 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.
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