Recall of Infant Liquid Ibuprofen Expanded Over Safety Concerns
The recall of infant liquid ibuprofen sold at large retailers such as CVS and Wal-Mart, has been expanded over concerns over toxicity. According to an NBC News report, the drug manufacturer Tris-Pharma, said that additional lots of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 ml, sold in 0.5-ounce bottles at CVS, Wal-Mart and Family Dollar Services may have higher concentrations of ibuprofen than what’s on the label. Routine tests found that some units contained 10 percent more ibuprofen than specified levels.
Risk of Toxicity
Normal levels per bottle are 50 mg of ibuprofen per 1.25 ml. 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. So far, no adverse events have been reported in connection with this recall. The Food and Drug Administration (FDA), which monitors drugs in the United States, said infants who are already vulnerable to the adverse effects of ibuprofen might be at a slightly higher risk if they receive medication from one of the affected bottles.
The higher concentration could lead to nausea, vomiting, diarrhea, headache, stomach bleeding and kidney damage, according to the drug maker. The original recall last November was for three batches of the ibuprofen drops. The new recall includes three more batches. Wal-Mart sells these products under the “Equate” label. CVS offers it under the “CVS Health” label and at Family Dollar, it is sold under the “Family Wellness Label.” For more information about this recall, consumers can call Tris-Pharma at 732-940-0358.
Dangerous and Defective Drugs
Drug companies have a responsibility to make medications that are safe for consumers to use. The recalled drugs in question are meant for the most vulnerable consumers – infants and toddlers. To sell medications that have high levels of toxicity shows a lack of quality control and a high degree of negligence.
If your child has been sickened or has suffered serious side effects as a result of these defective drugs, please contact an experienced product defect lawyer who will help protect your legal rights. We can help you secure fair compensation for damages including medical expenses, hospitalization costs, compensation for permanent injuries and disabilities and pain and suffering. The best product defect law firms will always offer free consultations and comprehensive case evaluations to victims and their families.