The National Agency for Food and Drugs Administration and Control (NAFDAC) wishes to inform healthcare professionals and the general public of the detection of falsified Tavanic® 500mg tablets, labelled with batch 4MW4C.
NAFDAC received a report concerning suspected falsification of Tavanic® 500mg tablet labelled with batch 4MW4C (Manufacturing Date: 05/2024, Expiry date: 04/2027). Following a stakeholder engagement and preliminary investigations, samples of the suspected product were submitted to NAFDAC for assessment, with an additional sample forwarded to the manufacturer’s anti-counterfeiting laboratory for further analysis.
Findings from the investigation revealed that the affected packs did not originate from the authorised supply chain. The falsified products were traced to purchases from the open drug market, Idumota, Lagos.
Detailed examination of the suspect packs showed deliberate misrepresentation of the product identity, including relabelling and packaging inconsistencies:
- The outer carton information falsely bears details consistent with a genuine batch (Batch No. 4MW4C, Manufacturing Date: 05/2024, Expiry date: 04/2027).
- The inner blister packs carry these details as removable stickers, with evidence of erasure of original batch information, indicating deliberate relabelling of an older (expired) product.
- Significant discrepancies were observed in the Mobile Authentication Service (MAS) label and print quality when compared with genuine retained samples.
- The MAS label on the falsified product (Mpdigree) differs from that of the genuine product (Sproxil)and does not correspond to the authorised distributor in Nigeria.
A comparison between genuine Tavanic® 500mg tablets and the falsified product is presented below to aid identification.
Comparison of Genuine and Falsified Tavanic® 500mg Tablets
Parameter | Genuine Tavanic® 500mg tablets | Falsified Tavanic® 500mg tablets |
Batch Number print quality | Uniform, high-quality printing | Inconsistent print quality |
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Inner Blister Pack Information
| Batch number, manufacturing, and expiry date printed directly on blister – not peelable | Batch number, manufacturing, and expiry date affixed as removable stickers |
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Consistent with the declared batch | Traced to an older expired batch (2PK3C, Expiry date: July 2025) | |
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MAS Label (Mobile Authentication Service) Batch Number print quality | Reflects authorised distributor (Assene Laborex) | MAS label text differs and does not correspond to authorised distributor |
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These discrepancies confirm that the product in question is falsified, as defined by the World Health Organisation: a medical product that deliberately misrepresents its identity, composition, or source.
Falsified Product details
Product Name | Tavanic® 500mg |
Stated Manufacturer | Sanofi |
Batch Number | 4MW4C |
Manufacturing Date | 05/2024 |
Expiry Date | 04/2027 |
Source | Open market (unauthorised supply chain) |
Risk Statement
Falsified medicines pose serious risks to public health. Such products may be ineffective, expired, or contain incorrect or substandard ingredients, potentially leading to treatment failure, adverse reactions, and increased risk of antimicrobial resistance.
NAFDAC wishes to emphasize that genuine Tavanic® 500mg tablets supplied through the authorised distribution channel remain safe, effective, and of assured quality.
Healthcare professionals and members of the public are advised to be vigilant and inspect medicines carefully before use.
Any suspected falsified Tavanic® 500mg tablets should be reported immediately to the nearest NAFDAC Office.
Medicines should be purchased only from licensed pharmacies and authorised distributors. In Nigeria, Assene Laborex Limited is the authorised distributor of Sanofi products, including Tavanic® 500mg.
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
Furthermore, note that this notice will be uploaded to the WHO Global Surveillance and Monitoring System (GSMS).
NAFDAC………. Customer-focused, Agency-minded!!!
