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(Last Updated On: October 9, 2022)

Public Alert No. 041/2022 – Recall of substandard dexamethasone products detected in Anambra State, Nigeria

October 8, 2022,

The National Agency for Food and Drugs Administration and Control (NAFDAC) is notifying Healthcare providers and the public of the recall of substandard dexamethasone tablets detected in Anambra State.

This recall is due to unsatisfactory results of analysis which showed that the samples were found to contain substandard amounts of dexamethasone (i.e. less than the amount stated on the labels). Some of the samples were also found to contain methylparaben and/or propylparaben in small amounts. Methylparaben and/or propylparaben is a preservative often used to give a product a longer shelf life. The presence of these preservatives in tablets are unusual and unnecessary and the use of these substances should be avoided, particularly in case of paediatric formulations.

Dexamethasone provides relief for inflamed areas of the body. It is used to treat a number of different conditions, such as inflammation (swelling), severe allergies, adrenal problems, arthritis, asthma, blood or bone marrow problems, kidney problems, skin conditions, and flare-ups of multiple sclerosis.

Possible Risk

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.

Consequently, NAFDAC has directed all concerned Marketing Authorization Holders (MAH) of the affected brands to initiate a nationwide recall of their products with immediate effect and submit updates of the recall to the Agency for effective monitoring.  

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%
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
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.
71 GG Dexamethasone 1 JIANGSU PENGYAO Geneith PHARM. A4-1598 200821 08/2020 08/2023 75.7%
81 GG Dexamethasone 1 JIANGSU PENGYAO Geneith PHARM. A4-1598 200821 08/2020 08/2023 78.4%
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)


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.
18² Xasten 1 JIANGSU PENGYAO VIXA PHARMACEUTICAL 04-6822 200925 09/2020 09/2023 81.2%
LTD (China)
19² Xasten 1 JIANGSU PENGYAO VIXA PHARMACEUTICAL 04-6822 200925 09/2020 09/2023 83.4%
LTD (China)
20 Zanelb 0.5 VAKS Pharma Pvt. Ltd. CHRISNELB B4-8496 V20169 08/2020 07/2023 79.7%

NAFDAC has heightened surveillance in the 36 States and the Federal Capital Territory, Abuja to  stop the distribution and sale of the above listed dexamethasone products.

All distributors, wholesalers, retailers and consumers in possession of the recalled products are implored to discontinue sale or use and submit stock to the nearest NAFDAC office.

Healthcare providers and other members of the public are to contact the nearest NAFDAC office with any information on distribution and sale of the recalled dexamethasone products.

Healthcare professionals and consumers are advised to report any suspicion of adverse drug reaction, substandard and falsified medicines to the nearest NAFDAC office, NAFDAC on 0800-162-3322 or via email: sf.alert@nafdac.gov.ng

NAFDAC……..Customer-focused, Agency-minded!!!

Signed Management

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