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Oral Suspension By Tris Pharma: Recall - Due to Potential Higher Concentrations of Ibuprofen
Voluntary recall: Select lot numbers of Infant Ibuprofen Concentrated Oral Suspension sold at Walmart, CVS and Family Dollar:
Complete information including affected lot numbers and images of the product labels are available at here.
As reported on the FDA website, on January 29, 2019 Tris Pharma is expanding the scope of its November 2018 recall by adding three (3) additional lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, to the retail (pharmacy) level. Some units from these batches have been found to have higher levels of Ibuprofen concentration.
Infants already susceptible to the adverse effects of ibuprofen may be at a slightly higher risk if they receive medication from an impacted bottle. There is a remote probability that infants, who may be more susceptible to a higher potency level of drug, may be more vulnerable to permanent NSAID-associated renal injury. Some units from these six (6) lots have been found to contain Ibuprofen as high as 10 percent above the specified limit. Studies have shown that safety issues or toxicity is generally accepted to be a concern in infants at doses in excess of 700 percent of the recommended dose.
To date, no serious adverse events have been reported related to this recall.
The product is used as a pain reliever/fever reducer and is packaged in ½ oz. and 1 oz. bottles. Tris Pharma, Inc. sold the affected lots of Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL to one customer, which distributed the lots into the US market. Tris Pharma, Inc. has notified its customer by urgent recall notice and is arranging for the return of the recalled product.
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.
Adverse reactions or quality problems associated with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax.
Complete information including affected lot numbers and images of the product labels are available at here.
As reported on the FDA website, on January 29, 2019 Tris Pharma is expanding the scope of its November 2018 recall by adding three (3) additional lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, to the retail (pharmacy) level. Some units from these batches have been found to have higher levels of Ibuprofen concentration.
Infants already susceptible to the adverse effects of ibuprofen may be at a slightly higher risk if they receive medication from an impacted bottle. There is a remote probability that infants, who may be more susceptible to a higher potency level of drug, may be more vulnerable to permanent NSAID-associated renal injury. Some units from these six (6) lots have been found to contain Ibuprofen as high as 10 percent above the specified limit. Studies have shown that safety issues or toxicity is generally accepted to be a concern in infants at doses in excess of 700 percent of the recommended dose.
To date, no serious adverse events have been reported related to this recall.
The product is used as a pain reliever/fever reducer and is packaged in ½ oz. and 1 oz. bottles. Tris Pharma, Inc. sold the affected lots of Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL to one customer, which distributed the lots into the US market. Tris Pharma, Inc. has notified its customer by urgent recall notice and is arranging for the return of the recalled product.
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.
Adverse reactions or quality problems associated with the use of this product may 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 here
- Regular Mail or Fax: Download form here 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
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