The National Agency for Food and Drugs Administration and Control (NAFDAC) has alerted healthcare providers and the public about a suspected counterfeit batch of Phesgo 600mg/600mg/10ml injection, labelled with batch number C5290S20.
In a statement on its official X handle on Thursday, the counterfeit product, according to NAFDAC, was flagged after a doctor from the Lagos University Teaching Hospital (LUTH), made a complaint.
NAFDAC disclosed that the suspected counterfeit drug, brought in by a patient, matched another previously identified counterfeit batch, C3809C51.
The agency stated further that the Marketing Authorisation Holder (MAH), Roche, reviewed images of the suspected product and confirmed it as falsified, adding that Roche identified several inconsistencies, including a non-existent batch number, incorrect language, missing tamper-evidence features and mismatched labels compared to genuine products.
The statement reads, “The National Agency for Food and Drugs Administration and Control (NAFDAC) wishes to inform healthcare providers and the public of a report of a suspected counterfeit Phesgo® 600mg/600mg/10ml, labelled with batch C5290S20.
“The Marketing Authorization Holder (MAH) Roche received a complaint from a doctor at Lagos University Teaching Hospital (LUTH-NSIA) reporting a suspected counterfeit Phesgo® 600mg/600mg, labelled with batch C5290S20. The product was reported to have been brought in by a patient for administration. It had not been administered at the time of the report, as it matched the previously reported counterfeit batch C3809C51.
“Although no sample was returned to Roche for investigation, only pictures displaying parts of a Phesgo® 600mg/600mg in a 10ml folding box and a labelled vial. Images of the suspected product were examined by Roche and compared to the genuine samples retained for reference. The investigation identified the following significant differences between the complaint sample pictures and the genuine materials which confirmed the falsified status of the suspected counterfeit batch of Phesgo® 600mg/600mg.”
The agency emphasized the risks of counterfeit drugs, warning that they undermine the safety and effectiveness of medicines.
It urged importers, distributors, and healthcare professionals to be vigilant and ensure medical products are sourced from authorized suppliers.
Healthcare providers and consumers were advised to report any suspected counterfeit drugs to NAFDAC via their offices, helpline, or email.
“All NAFDAC zonal directors and state coordinators have been directed to carry out surveillance and mop up the counterfeit products within the zones and states. Importers, distributors, retailers, healthcare professionals and caregivers are hereby advised to exercise caution and vigilance within the supply chain to avoid importing, distributing, selling, and using counterfeit products. All medical products must be obtained from authorized/licensed suppliers.
“The products’ authenticity and physical condition should be carefully checked. Healthcare professionals and consumers are advised to report any suspicion of the sale of substandard and falsified medicines or medical devices to the nearest NAFDAC office, or call NAFDAC on 0800-162-3322 or via email: sf.alert@nafdac.gov.ng.
“Similarly, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of medicinal products or devices 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, ” it advised
The agency reassured the public that efforts to identify and remove counterfeit products from circulation were ongoing.
The PUNCH
