In accordance with its mandate to safeguard public health, NAFDAC hereby issues a formal notice of blacklisting of OCEAN PLUS PHARM LTD, no 1, Isieke Street, Asaba, Delta State.
Following routine post-marketing surveillance, samples of a batch of unregistered CHRICLAV (Amoxicillin/ Clavulanic acid) dry powder for oral suspension manufactured by CHRICURE PHARM, 174 – B, 176 NEWSHARA INDUSTRIAL ESTATE RESAPURE, INDIA, and marketed by OCEAN PLUS PHARM Ltd were collected from Coordinated Wholesale Centre (CWC), Kano, and analysed in NAFDAC’s ISO-17025-accredited Laboratory, which revealed:
- Amoxicillin: 0mg (0%), Clavulanic: 0mg (0%)
This indicates that the product is Falsified and poses serious risks to public health, including:
- Therapeutic failure
- Development of antimicrobial resistance
- Increased risk of complications
- Misleading clinical outcomes
Further investigations revealed that the MAH is not listed in the NAFDAC database. All attempts to trace the MAH have been unsuccessful.
In view of this, the company is not authorized to distribute quality medical products for public use. Therefore, it is blacklisted, and the public should refrain from purchasing any products distributed by Ocean Plus Pharma Ltd.
NAFDAC’s blacklisting mechanism serves to shield public health by:
- Prohibiting the sale, distribution, or use of all products associated with the erring firm.
- Alerting healthcare providers and consumers to potential safety hazards.
For Ocean Plus Pharma, blacklisting entails:
- Immediate cessation and dealing (manufacturing, importation, exportation, distribution, and sales activities) in all forms of health products.
- Potential prosecution for offenses under the NAFDAC laws and regulations.
All NAFDAC zonal directors and state coordinators have been directed to carry out surveillance and mop up the substandard/falsified products within their zones and states.
NAFDAC implores distributors, suppliers, wholesalers, healthcare providers, and patients to exercise caution and vigilance within the supply chain to avoid distribution, sale, administration, and use of the products marketed by Ocean Plus Pharma. All medical products must be obtained from genuinely authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.
If you have the products mentioned above or any product marketed or distributed by Ocean Plus Pharma Ltd, please stop selling or using them immediately and submit your stock to the nearest NAFDAC office. If you or someone you know has used any of these products and experienced adverse reactions or events, we strongly recommend seeking immediate medical advice from a qualified healthcare professional.
Healthcare professionals and consumers are advised to report any suspicion of substandard and falsified medicines to the nearest NAFDAC office, 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 the medicinal product 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
Thank you.
Prof. Mojisola Christianah Adeyeye FAS
Director General
