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Public Alert No. 0015/2019 – Expanded Recall Of Infants’ Ibuprofen Concentrated Oral Suspension

July 15, 2019,

The National Agency for Food and Drug Administration and Control has been informed that Spanish drug manufacturer, Tris Pharma is voluntary recalling one lot of Ibuprofen Concentrated Oral Suspension due to potentially high concentrations of the drug.

Ibuprofen Oral Suspension is a Nonsteroidal Anti-Inflammatory Drug (NSAID) typically used to treat fever or pain. It is also used to relieve discomfort from teething and ear infections. It is generally safe when taken as directed by physician. However, excessive doses of Ibuprofen can be very dangerous, especially in infants who may be more susceptible to higher potency of the drug which can cause renal injury.

Product information

Product name: Infant Ibuprofen Concentrated Oral Suspension.

Product manufacturers: Tris Pharma Inc. USA.

Details of additional Ibuprofen oral suspension being recalled are:

LOT NO NDC EXPIRATION DATE DESCRIPTION COMPANY
4718 59779-925-23 12/19 CVS Health: infants ibuprofen concentrated oral suspension, USP; 50mg per 1.25ml, in o.5 oz. bottle  

CVS Pharm

NAFDAC implores all importers, wholesalers and retailers to immediately stop the importation, distribution and sale of the product.

Health care providers and members of the public are also advised to stop the administration and use of the affected products to avoid negative health implications.

Healthcare providers and anyone in possession of the affected products should submit them to the nearest NAFDAC office.

Consumers are advised to report adverse events related to the use on any of these products to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks) or via pharmacovigilance@nafdac.gov.ng

NAFDAC…………Safeguarding the health of the Nation!!!

Signed Management