By Jerome kanyika
Please find attached the laboratory analysis report for Benylin Paediatric Syrup, Batch 329304 (which has never been imported batch into Zambia)
Following a notice received from NATIONAL AGENCY FOR FOOD AND DRUG ADMINISTRATION AND CONTROL (NAFDAC) of Nigeria claiming the presence of DEG in Benylin Paediatric above the limit of 0.1%, a third-party laboratory was used for this analysis.
The third-party laboratory, (located in Poland) broke the tamper-evident seal on the packaging of a retain sample provided by the manufacturer and removed an aliquot for the test,
Neither Diethylene Glycol (DEG) nor Ethylene Glycol (EG) were detected in this sample.
The lab also tested 2 bottles of an expired lot of the medication as a control (no EG or DEG was detected in the controls) and further tested a sample spiked with EG and DEG, to demonstrate that the method was working properly and that the compounds, if present, are guaranteed to be detected.
Note that the contracted laboratory used the published WHO recommended method of Gas Chromatography to conduct this analysis.
Considering these results, the Manufacturer has been in communication with NAFDAC to ascertain the authenticity of the sampled product and the testing methodology that they used.
Unfortunately, NAFDAC claims to have depleted all the samples and thus is unable to provide any of the units that they used to conduct these tests.
Additionally, they have, to date, not shared their laboratory analysis report.
Also note that Regulatory Authorities such as Ghana FDA have tested samples of Benylin Paediatric (current batches on the market) and have found no traces of DEG or EG.
This has been published on public alert dated 12th april, 2024 (FDE/CSD/CPE/PRS/24/006) which is available on their website.
I ALWAYS ASK THESE PEOPLE TO ASK US THE EXPERTS IN THIS FIELD BEFORE ALARMING THE NATION AND DESTROY A GOOD DRUG NAME OR BRAND.
