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Public Alert No. 01/2023 – Alert on Substandard (contaminated) METHOTREXTM 50mg identified in the WHO Eastern Mediterranean region

January 9, 2023,

The National Agency for Food and Drugs Administration and Control (NAFDAC) is notifying Healthcare providers that one batch of substandard (contaminated) METHOTREXTM (methotrexate) 50mg, have been identified in two countries (Yemen and Lebanon) in the WHO Eastern Mediterranean region.

The stated manufacturer, CELON Laboratories Pvt Ltd., has confirmed to WHO that the stated batch number, manufacturing and expiry dates combination referenced on the product match their internal records. Although, they have not had access to samples of the suspect products for their own confirmatory testing.

On the other hand, the health authorities in both Yemen and Lebanon conducted microbiological testing on the remaining unopened vials of METHOTREXTM 50mg following reports of adverse events in pediatric patients receiving the medication. Results in both countries were positive for Pseudomonas aeruginosa, indicating contamination of the products.

Pseudomonas aeruginosa bloodstream infection is a serious infection that may lead to death and any product that has any contamination and is administered directly in the body would present serious risks to patients.

Methotrexate is a chemotherapy agent and immune system suppressant. It is used for the treatment of a wide variety of cancers as well as severe psoriasis, severe rheumatoid arthritis, and juvenile rheumatoid arthritis. It may be given by intrathecal, intramuscular, intravenous, or intra-arterial routes. Patients receiving methotrexate treatment may have weakened immune systems and be more vulnerable to opportunistic infections.

Product details

The details of the contaminated product are as follows:

Product Name METHOTREXTM 50mg
Declared active ingredient Methotrexate 50mg/2mL
Stated Manufacturer CELON LABORATORIES, PVT LTD – Telangana State, India
Stated to be marketed by RMPL PHARMA LLP – Mumbai
Batch number MTI2101BAQ
Expiry date 12/2022
Date of manufacture 01/2021

METHOTREXTM 50mg batch MTI2101BAQ was intended to be sold exclusively on the Indian market. Availability of the batch in Yemen and Lebanon proves the product was procured outside the regulated supply chain. Therefore, the stated manufacturer cannot guarantee the safety of this product which was not destined to these markets.

However, it is likely that this product may have been distributed to other countries through informal markets. It is important to detect and remove this contaminated product from circulation to prevent harm to patients. Substandard medical products are products that fail to meet either their quality standards or specifications and are therefore “out of specification”.

The product is not in NAFDAC’s database.  However, NAFDAC implores importers, distributors, retailers and healthcare providers to always exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale and administration or use of falsified or substandard medicinal products. All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked. 

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

Healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of medicinal product to the nearest NAFDAC office, via pharmacovigilance@nafdac.gov.ng or via the NAFDAC ADR e-Reporting platform available at www.nafdac.gov.ng

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

Signed Management

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