,
The National Agency for Food and Drugs Administration and Control (NAFDAC) is notifying Healthcare providers and the public of the detection of substandard dexamethasone tablets purchased in Anambra State following cooperation between an academic pharmaceutical institute in Europe and a partner organization in Africa.
Twenty-two (22) samples of dexamethasone tablets were purchased in Anambra state and subjected to quantitative analysis using High Performance Liquid Chromatography (HPLC). The result of analysis showed that the samples were found to contain substandard amounts of dexamethasone (i.e. less than the amount stated on the label).
The administration of the subtherapeutic doses of dexamethasone in the products or any substandard and falsified medical products may cause harm to patients and lead to treatment failure. They can also lead to loss of confidence in medicines, healthcare providers and health systems.
Some of the samples were also found to contain methylparaben and/or propylparaben in small amounts. The use of these substances should be avoided, particularly in case of paediatric formulations.
Methylparaben and/or propylparaben is a preservative often used to give a product a longer shelf life.
Product Details
The details of the substandard dexamethasone tablets are listed below;
| No | Product name + strength | Stated manufacturer | Stated marketing | NAFDAC- | Batch No | Date of | Date of | Assay | |
| (country) | authorization holder | Reg. No | manufac | expiry | (HPLC) | ||||
| (country) | ture | ||||||||
| 1 | Destrax | 0.5 | JIANGSU PENGYAO | ELIONA | B4-3876 | 181201 | 12/2018 | 12/2021 | 42.9% |
| PHARMACEUTICALS CO. | PHARMACEUTICALS LTD. | ||||||||
| LTD (China) | (Nigeria) | ||||||||
| 2 | Dexacortin | 0.5 | Maxwell Life Science Pvt. | Malven Medics Int‘l Ltd. | 04-2446 | ET9514 | 12/2019 | 11/2022 | 78.3% |
| Ltd. (India) | (Nigeria) | ||||||||
| 3 | Dexacure | 0.5 | Unicure Pharmaceutical | A4-7117 | 201101 | 11/2020 | 10/2023 | 88.1% | |
| Ltd. (Nigeria) | |||||||||
| 4 | Dexacure | 0.5 | Unicure Pharmaceutical | A4-7117 | 210201 | 02/2021 | 01/2024 | 89.6% | |
| Ltd. (Nigeria) | |||||||||
| 5 | Dexalab | 0.5 | Laborate Pharmaceuticals | Embassy Pharmaceutical | 04-5413 | KDSTE- | 02/2020 | 01/2023 | 89.0% |
| India Ltd. (India) | und Chemicals LTD. | 003 | |||||||
| (Nigeria) | |||||||||
| 6 | Dexamethasone 0.5 | 0.5 | Surmount Laboratories | TOPSEA STANDARD | B4-9983 | TD9003 | 10/2019 | 09/2022 | 79.4% |
| Private Limited (India) | Pharmaceutical Co. Ltd. | ||||||||
| (Nigeria) | |||||||||
| 71 | GG Dexamethasone | 1 | JIANGSU PENGYAO | Geneith PHARM. | A4-1598 | 200821 | 08/2020 | 08/2023 | 75.7% |
| Tablets | PHARMACEUTICALS INC. | LIMITED (Nigeria) | |||||||
| (China) | |||||||||
| 81 | GG Dexamethasone | 1 | JIANGSU PENGYAO | Geneith PHARM. | A4-1598 | 200821 | 08/2020 | 08/2023 | 78.4% |
| Tablets | PHARMACEUTICALS INC. | LIMITED (Nigeria) | |||||||
| (China) | |||||||||
| 9 | Me cure | 0.5 | Me Cure Industries Ltd. | A4-0201 | DC.319 | 06/2021 | 05/2024 | 88.6% | |
| Dexamethasone | (Nigeria) | ||||||||
| 10 | Nkoyo | 0.5 | AR Lifesciences (India) | Nkoyo Chemists | 04-8665 | L263 | 09/2020 | 08/2023 | 70.7% |
| Dexamethasone | (Nigeria) | ||||||||
| 11 | Nkoyo | 0.5 | McCOY Pharma Pvt. Ltd. | Nkoyo Chemists | 04-8665 | L20072 | 05/2020 | 04/2023 | 86.2% |
| Dexamethasone | (India) | (Nigeria) | |||||||
| 12 | Nkoyo | 0.5 | Mancare | Nkoyo Chemists | 04-8665 | TVL55 | 12/2020 | 11/2023 | 89.3% |
| Dexamethasone | PHARMACEUTICALS PVT. | (Nigeria) | |||||||
| LTD. (India) | |||||||||
| 13 | Nkoyo | 0.5 | Astamed Healthcare (I) | Nkoyo Chemists | 04-8665 | 1008 | 06/2021 | 05/2024 | 88.5% |
| Dexamethasone | Pvt. Ltd. (India) | (Nigeria) | |||||||
| 14 | Nkoyo | 0.5 | Maxwell Life Science Pvt. | Nkoyo Chemists | 04-8665 | LT110 | 11/2021 | 10/2025 | 89.7% |
| Dexamethasone | Ltd (India) | (Nigeria) | |||||||
| 15 | Pauco | 0.5 | PAUCO Pharmaceutical | A4-1036 | 016 | 10/2020 | 09/2024 | 81.2% | |
| Dexamethasone | Ind. Ltd. (Nigeria) | ||||||||
| tablets | |||||||||
| 16 | Rich Dexa | 0.5 | Brussels Laboratories Pvt | Solpharm Chemical | B4-5389 | Z19003 | 08/2019 | 07/2022 | 51.3% |
| Ltd. (India) | Industries LTD. (Nigeria) | ||||||||
| 17 | Trust Time | 0.5 | DUPEN LABORATORIES | TRUST TIME | B4-5651 | A009 | 02/2020 | 01/2023 | 80.8% |
| Dexamethasone | PVT. LTD. (India) | PHARMACEUTICAL LTD. | |||||||
| (Nigeria) | |||||||||
| 18² | Xasten | 1 | JIANGSU PENGYAO | VIXA PHARMACEUTICAL | 04-6822 | 200925 | 09/2020 | 09/2023 | 81.2% |
| PHARMACEUTICAL CO., | CO., LTD. (Nigeria) | ||||||||
| LTD (China) | |||||||||
| 19² | Xasten | 1 | JIANGSU PENGYAO | VIXA PHARMACEUTICAL | 04-6822 | 200925 | 09/2020 | 09/2023 | 83.4% |
| PHARMACEUTICAL CO., | CO., LTD. (Nigeria) | ||||||||
| LTD (China) | |||||||||
| 20 | Zanelb | 0.5 | VAKS Pharma Pvt. Ltd. | CHRISNELB | B4-8496 | V20169 | 08/2020 | 07/2023 | 79.7% |
| (India) | PHARMACEUTICAL LTD. |
Product Image
NAFDAC implores importers, distributors, retailers and consumers to exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale and use of the substandard dexamethasone tablet. All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.
Members of the public in possession of the listed dexamethasone products are advised to discontinue sale or use and submit stock to the nearest NAFDAC office.
If you have these substandard products, please DO NOT use them. If you, or someone you know, have used these products or suffered any adverse reaction/event after use, you are advised to seek immediate medical advice from a qualified healthcare professional.
Healthcare professionals and consumers are encouraged to report any suspicion of adverse drug reaction and substandard and falsified medicines to NAFDAC on 0800-162-3322 or email: sf.alert@nafdac.gov.ng
NAFDAC……..Customer-focused, Agency-minded!!!
Signed Management
