** NAFDAC joins the Federal Ministry of Health and Social Welfare, nutrition partners, and the rest of the world in celebrating World Breastfeeding Week 2024 from 1st to 7th August. The theme for this year is ' Closing the gap: Breastfeeding Support for All'. Let us all join hands to protect, promote, and support breastfeeding. Happy World Breastfeeding Week! ** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-6 ** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-6 ** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-6
** NAFDAC joins the Federal Ministry of Health and Social Welfare, nutrition partners, and the rest of the world in celebrating World Breastfeeding Week 2024 from 1st to 7th August. The theme for this year is ' Closing the gap: Breastfeeding Support for All'. Let us all join hands to protect, promote, and support breastfeeding. Happy World Breastfeeding Week! ** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-6 ** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-6 ** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-6
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  5. Public Alert No. 037/2023 – Alert on Substandard (contaminated) syrup and suspension medicines identified in…

Public Alert No. 037/2023 – Alert on Substandard (contaminated) syrup and suspension medicines identified in the WHO Regions of the Americas, Eastern Mediterranean, South-East Asia and Western Pacific

The National Agency for Food and Drugs Administration and Control (NAFDAC) is notifying Healthcare providers and the general public of the WHO Medical Product Alert referring to five different Oral liquid dosage forms (syrup and suspension) detected in the Maldives and Pakistan. Some of the affected products have also been detected in Belize, Fiji and Lao People’s Democratic Republic.

The five products are ALERGO Syrup, EMIDONE Suspension, MUCORID Syrup, ULCOFIN Suspension and ZINCELL Syrup. A total of 23 batches of these products are affected. The stated manufacturer of all the affected products is 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) 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% 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). According to DRAP, a 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.

As a precautionary measure PHARMIX LABORATORIES has been instructed by DRAP to stop production of all oral liquid dosage medicines and issued a Recall Alert for the five different oral dosage forms manufactured by PHARMIX LABORATORIES.

Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal. Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death.

Manufacturers of liquid dosage forms, especially syrups that contain excipients at risk for contamination with EG/DEG, e.g. glycol, sorbitol, and/or glycerin/glycerol, are urged to follow GMP requirements and to test each container of each incoming batch for ethylene glycol and diethylene glycol before using the excipients in the production of medicines.

Product Details

The details of the affected products are as follows;

Annex 1 of WHO Medical Product Alert No. 8/2023
Stated Manufacturer: Pharmix Laboratories (Pvt.) Ltd. Pakistan
Product NameBatchManufacture dateExpiry dateIdentified In
 Alergo syrupL12627/12/202126/12/2023Pakistan
B22016/02/202215/02/2024Belize, Fiji, Lao PDR, Maldives, Pakistan
G20405/07/202204/07/2024Maldives
L21012/12/202211/12/2024Maldives
K22216/11/202215/11/2024Maldives
J24226/10/202225/10/2024Maldives
Emidone SuspensionB22725/02/202224/02/2024Pakistan
Mucorid SyrupA21010/01/202209/01/2024Pakistan
A21119/01/202218/01/2024Pakistan
A21219/01/202218/01/2024Pakistan
A23029/01/202228/01/2024Pakistan
A23029/01/202228/01/2024Pakistan
B20103/02/202202/02/2024Pakistan
B20103/02/202202/02/2024Pakistan
B22418/02/202217/02/2024Pakistan
B22521/02/202220/02/2024Pakistan
C21008/03/202207/03/2024Pakistan
C22721/03/202220/02/2024Pakistan
L11113/12/202112/12/2023Pakistan
L12120/12/202119/12/2023Pakistan
 Ulcofin SuspensionB20908/02/202207/02/2024Pakistan
C22317/03/202216/03/2024Pakistan
Zincell SyrupC21811/03/202210/03/2024Pakistan

These substandard products referenced in this alert are unsafe and their use, especially in children, may result in serious injury or death.

Although these products are not registered by NAFDAC, they may have been distributed, through formal and informal markets, to other countries or regions including Nigeria.

NAFDAC implores importers, distributors, retailers and consumers to exercise caution and increase vigilance within the supply chain to avoid the importation, distribution, sale and use of the substandard cough syrups. 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 above listed products are advised not to sale or use the products, instead they are to submit stock to the nearest NAFDAC office.

Seek immediate medical advice from a qualified healthcare professional if you have used the product, or suffered an adverse reaction/event having used the products.

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

Similarly, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of the medicinal product to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng or via the Med- safety application available for download on android and IOS stores or via e-mail on pharmacovigilance@nafdac.gov.ng 

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

Signed Management

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