The National Agency for Food and Drug Administration and Control (NAFDAC) is alerting healthcare providers and the public about a report concerning the circulation of counterfeit and unregistered Otrivin Nasal drops (0.05%) for children and (0.01%) for adults in Nigeria.
The Post Marketing Surveillance (PMS) Directorate of the Agency received a consumer complaint of an unregistered Otrivin Nasal drop being circulated.
Investigation and clarification from the Marketing Authorization Holder (MAH), GlaxoSmithKline, revealed that they are not currently importing any products. The MAH also confirmed that all products in circulation are counterfeits.
Nasal drops are used to relieve congestion, treat allergies, reduce inflammation, and soothe dryness by delivering medication or saline directly into the nasal passages.
Potential Risks
The integrity of a product relies heavily on its compliance with regulatory requirements. Unregistered products lacking regulatory approval pose significant risks to public health, as they may contain harmful, substandard, or ineffective ingredients. This can lead to adverse health outcomes and treatment failures.
Product details:
The details of the Unregistered Counterfeit product are as follows.
Product Name | Description | NAFDAC Reg. No | Batch No | Manufacturing date | Expiry date |
Otrivin Nasal Drops (0.05%) Children | Original | 04-5350 | – | – | – |
| Counterfeit | – | 7U8T | 05/2024 | 05/2027 |
Otrivin Nasal Drops (0.01%) Adult | Original | 04-0026 | – | – | – |
| Counterfeit | – | SU8X | 05/2024 | 05/2027 |
Product Photo:
Original Approved Packaging (Children)
Counterfeit Otrivin (Children)
Original Approved Packaging (Adult)
Counterfeit Otrivin (Adult)
All NAFDAC zonal directors and state coordinators have been instructed to conduct surveillance and eliminate any unregistered or counterfeit products discovered within their zones and states.
Distributors, retailers, healthcare professionals, and caregivers are advised to exercise caution and vigilance throughout the supply chain to prevent the distribution, sale, and use of substandard products. All medical products must be obtained from authorized and licensed suppliers. Additionally, the authenticity and physical condition of these products should be thoroughly 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, 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
For complaints, you can call the Reforms Unit on the following lines: 09097630506, 09097630507, or email: reforms@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!!!
