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Public Alert No. 040/2022 – Alert on Detection of substandard dexamethasone products in Nigeria

October 7, 2022,

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
  [mg]   (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

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