,
The National Agency for Food and Drugs Administration and Control (NAFDAC) is notifying Healthcare providers and the public of eight (8) substandard products, identified in the WHO Region of South-East Asia. These products were identified in Indonesia and publicly reported by the national regulatory authority (Badan POM) on 20 and 30 October 2022.
These products contain unacceptable amounts of ethylene glycol and/or diethylene glycol as contaminants: this has been confirmed by laboratory analysis of samples by the authorities in Indonesia. To date, these products have been identified in Indonesia. They may however have marketing authorizations in other countries and may have been distributed, through informal markets, to other countries or regions including Nigeria.
The products are not registered by NAFDAC, therefore should not be in circulation.
The details of the substandard products are as follows;
| Product Name | TERMOREX | FLURIN DMP | UNIBEBI COUGH SYRUP | UNIBEBI DEMAM
PARACETAMOL DROPS |
| Reported active ingredients | Paracetamol | Paracetamol, Pseudoephedrine HCl,
Dextromethorphan HBr, Chlorpheniramine Maleate |
Paracetamol, Guaifenesin, Chlorphenamine Maleate | Paracetamol |
| Stated manufacturer | PT Konimex | PT Yarindo Farmatama | PT Universal Pharmaceutical Industries | PT Universal Pharmaceutical Industries |
| Batch number | AUG22A06 | All batches | All batches | All batches |
| Mfg. date | AUG 2022 | N/A | N/A | N/A |
| Exp. date | AUG 2025 | N/A | N/A | N/A |
| Packaging language | Bahasa Indonesia | Bahasa Indonesia | Bahasa Indonesia | Bahasa Indonesia |
Available Images
| Product Name | UNIBEBI DEMAM PARACETAMOL SYRUP | PARACETAMOL DROPS | PARACETAMOL SYRUP
(mint)
|
VIPCOL SYRUP |
| Reported active ingredients | Paracetamol | Paracetamol | Paracetamol | Paracetamol, Guaifenesin, Chlorphenamine Maleate |
| Stated manufacturer | PT Universal Pharmaceutical Industries | PT Afi Farma | PT Afi Farma | PT Afi Farma |
| Batch number | All batches | All batches | All batches | All batches |
| Mfg. date | N/A
|
N/A
|
N/A
|
N/A
|
| Exp. date | N/A
|
N/A
|
N/A
|
N/A
|
| Packaging language | Bahasa Indonesia | Bahasa Indonesia | Bahasa Indonesia | Bahasa Indonesia |
Available Images
NAFDAC advise to wholesalers, distributors, and pharmacies is that medicines should be obtained from authorized/licensed suppliers. Increased vigilance is hereby encouraged within the supply chain to avoid infiltration of the substandard products. The products’ authenticity, physical condition and labels should be carefully checked.
NAFDAC implores healthcare providers to ensure vigilance to prevent the administration of substandard products to unsuspecting patients. Members of the public in possession of the above substandard products are advised to discontinue sale or use and submit stock to the nearest NAFDAC office.
Health care providers and the public should notify the nearest NAFDAC office of any information concerning the distribution, sale, and use of any substandard product. 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
