NEWS

NAFDAC Alerts Nigerians On Substandard, Contaminated Syrup

The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a public alert, referencing five potentially contaminated syrups reportedly circulating within World Health Organisation (WHO) regions.

According to the alert (No. 037/2023) signed by Prof. Mojisola Adeyeye, Director-General of NAFDAC, these oral liquid dosage forms were identified in the Maldives and Pakistan, with some batches also found in Belize, Fiji, and Lao People’s Democratic Republic.

The affected products include ALERGO Syrup, EMIDONE Suspension, MUCORID Syrup, ULCOFIN Suspension, and ZINCELL Syrup, totaling 23 affected batches, all linked to PHARMIX LABORATORIES (PVT.) LTD (Pakistan).

“In November 2023, samples of five different batches of ALERGO syrup were screened for non-compliance by the quality control laboratory of the Maldives Food and Drug Authority (MFDA).

“This is in accordance with the Thin Layer Chromatography (TLC) test for Diethylene Glycol and Ethylene Glycol for inclusion in the International Pharmacopoeia.

“The routine screening detected potentially unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.

“Laboratory testing conducted by the Therapeutic Goods Administration of Australia (TGA) confirmed that all five batches
were contaminated with ethylene glycol at levels ranging from 0.62 to 0.82 per cent w/w relative to the accepted limit of not more than 0.10% w/w.

“A follow-on inspection of PHARMIX LABORATORIES (PVT.) LTD was conducted by the Drug Regulatory Authority of Pakistan (DRAP).

“The DRAP review of the manufacturing facility and manufacturing records suggested that diethylene glycol/ethylene glycol as contaminants may be present in other products and batches manufactured by PHARMIX LABORATORIES (PVT.) LTD.

“The safety and quality of these products can, therefore, not be guaranteed,” Adeyeye quoted DRAP as saying.

The head of NAFDAC noted that DRAP had directed PHARMIX LABORATORIES to halt the production of all oral liquid dosage medications and issued a Recall Alert for the five distinct oral dosages made by the company as a preventive step.

She highlighted that Diethylene Glycol and Ethylene Glycol are harmful to humans if ingested and can be fatal, causing symptoms such as abdominal pain, vomiting, diarrhea, inability to urinate, headache, altered mental state, and acute kidney injury, potentially leading to death.

Stressing the risk of contamination of liquid dosage forms containing excipients like glycol, sorbitol, and/or glycerin/glycerol with EG/DEG, she emphasized that the referenced substandard products are unsafe, especially for children, and might cause severe harm or death.

Although these products are not registered by NAFDAC, she cautioned that they might have been distributed via formal and informal markets in various countries, including Nigeria.

She urged importers, distributors, retailers, and consumers to be vigilant and cautious within the supply chain to prevent the importation, distribution, sale, and use of inferior cough syrups.

Advising the public against selling or using the listed products, she recommended surrendering them to the nearest NAFDAC office and seeking immediate medical advice from qualified healthcare professionals for those who might have used these products.

She also encouraged healthcare professionals and consumers to report any suspicion of adverse drug reactions, substandard, or falsified medicines to the nearest NAFDAC office, via phone or email, and to report adverse effects through various channels such as the NAFDAC website, the Med-safety application, or email.

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