The National Agency for Food and Drug Administration and Control (NAFDAC) received a notification that the United States Food and Drug Administration (USFDA) has announced the recall of approximately 90,000 bottles of Children’s Ibuprofen Oral Suspension, USP (100 mg/5 mL) due to the presence of foreign material in the product.
Strides Pharma Inc. initiated the recall following consumer complaints of a “gel-like mass” and “black particles” observed in the oral suspension.
Ibuprofen Oral Suspension, USP (100 mg/5 mL) is a medication for children, intended for pain relief from the common cold, flu, sore throat, headache, and toothache, and for reducing fever.
POTENTIAL HEALTH RISKS
The presence of foreign material in medicinal products may compromise product quality, safety, and efficacy. Administration of contaminated oral suspensions may potentially result in adverse reactions, particularly in children, and may present choking or gastrointestinal risks depending on the nature of the contaminant.
PRODUCT DETAILS
The details of the affected products are as follows:
Product Name: Children’s Ibuprofen Oral Suspension, USP
Strength: 100 mg/5 mL
Dosage Form: Oral Suspension
Pack Size: 4 fl. oz. (120 mL) bottles
Product Manufacturer: Strides Pharma Inc., India (manufactured the product for Taro Pharmaceuticals U.S.A., Inc.)
Affected Lot Numbers: 7261973A and 7261974A
Expiry Date: 31 January 2027
Quantity Recalled: Approximately 90,000 bottles distributed nationwide in the United States.
Product Image
Although the affected product was distributed and recalled within the United States, NAFDAC remains committed to safeguarding public health and will continue surveillance activities to ensure the quality, safety, and efficacy of medicines circulating in Nigeria and prevent the recalled products from entering the Nigerian supply chain through authorized or unauthorized channels.
All NAFDAC zonal directors and state coordinators have been directed to conduct surveillance and mop up the product if found in their zones and states.
Importers, distributors, retailers, healthcare professionals, and caregivers are advised to exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale, and use of the recalled products. All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.
Healthcare providers and healthcare facilities should immediately inspect their inventories and quarantine any affected batches if identified.
Parents and caregivers who have the affected product or may have given it to their children should stop using it immediately and seek medical advice if any unusual reactions are observed.
Furthermore, healthcare providers and caregivers are also encouraged to report adverse events or side effects related to the use of any medicinal products to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng, or via the Med-safety application available for download on Android and IOS stores, or via e-mail on pharmacovigilance@nafdac.gov.ng
For complaints, you can call the Reforms Unit on the following lines: 09097630506, 09097630507, or email: reforms@nafdac.gov.ng
NAFDAC………. Customer-focused, Agency-minded!!!
