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FDA: Infants' Ibuprofen sold at Walmart, CVS Pharmacy recalled

01/03/2020 12:00:00

The FDA has recalled three Ibuprofen Oral Suspension Drops due to higher levels of Ibuprofen found in some of the batches. 

The company, Monmouth Junction, NJ, Tris Pharma, Inc., says infants vulnerable to the adverse effects of ibuprofen may be at a slightly higher risk if they receive the medicine from an impacted bottle. It could possibly lead to a permanent NSAID-associated renal injury. 

Some of the effected bottles have been found to contain as high as a 10% increase of the Ibuprofen specific limit. The three recalled bottles are sold at Wal-Mart Stores and CVS Pharmacy. 

 

The recalled items are described as the following: 

  • CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 0.5 oz. bottle - expiration 12/19
  • Equate: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 1.0 oz. bottle - expiration 02/19
  • CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 1.0 oz. bottle - expiration 02/19

Officials say that they have not had any reports yet of serious adverse events related to the recall. 

 

Consumers with questions about the recall are asked to contact Tris Customer Service by 732-940-0358 (Monday through Friday, 8:00 AM ET- 5:00 PM PT) or via email at micc_tris@vigilarebp.com. If you see your child experiencing any problems that may be related to taking or using the drug product, contact your physician or healthcare provider. 

Consumers with adverse reactions or quality problems may also report it to the FDA MedWatch Adverse Event Reporting program by the following options: 

This recall follows three other Ibuprofen Oral Suspension Drops pulled off the shelves back in November 2018. 

Article from: https://www.kctv5.com/
Child Prodigy Children's Center
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