TWO common drugs used to treat colds and bacterial infections have been withdrawn from Bahrain’s market after they were found to have “foul smell and defective packaging”.
The defective batches of Cefuzime 500mg and Profinal 100mg/5ml from Gulf Pharmaceutical Industries (Julphar) are being recalled following a circular issued by the National Health Regulatory Authority (NHRA) yesterday.
Cefuzime, a prescription drug available under the brand names Ceftin and Zinacef, is an antibiotic used to treat bacterial infections, while Profinal is used to reduce body temperature and offer pain relief for inflammatory conditions and is generally prescribed to children.
This means a total of eight medications from the UAE-based manufacturer have been pulled off Bahrain’s shelves after failing to meet GCC standards since July last year.
“All health professionals and services are asked to stop the use of the batch of Cefuzime 500mg tablets produced by Gulf Pharmaceutical Industries (Julphar) because of a defect in the quality of the product and due to the presence of foul smell and bulging packaging,” said the NHRA in a statement.
“The NHRA has received from the Julphar scientific office a report on the existence of the defect in the quality of preparation of the tablet.
“The NHRA also issues a circular to withdraw another drug product, Profinal, after receiving similar notice from the manufacturer for the same reasons.”
The GDN reported in January that the NHRA followed the UAE and Oman in banning the sale and prescription of Zordyl Mouthwash as it contained “harmful impurities”.
This followed the withdrawal of aspirin medication Jusprin 81mg earlier that month.
Other Julphar drugs withdrawn in September last year included all concentrations of Enoxirt, select operating numbers of Narapril 5mg, 10mg and 20mg and two variants of the Julmentin injection, while in July the Glynase 5mg tablet, a common drug in the treatment of diabetes, was withdrawn from the market due to concerns about its effectiveness.
“Whenever we receive notification from the country of origin of a factory or the scientific office in a factory itself stating that one batch is not produced according to the quality requirement, like improper packaging or there is a suspected odour, we immediately withdraw, and we don’t take any risk,” NHRA chief executive Dr Maryam Al Jalahma told the GDN yesterday.
“That does not mean withdrawing all of these drugs – it is only this batch which reached Bahrain, where there was a suspected odour that was immediately removed.
“The drugs belonging to this batch that are sold, stored or distributed to hospitals, the agent is responsible to withdraw all of it. And the hospitals, which have prescribed it, are responsible to call the patients and recall it. This is the system that we follow.
“With Julphar, all products with which we have an issue with is kept on pending status.
“However, as certified by the country of origin, all other products are safe and we cannot take any action on the manufacturer.”
The GDN previously reported on a temporary ban imposed on Julphar drugs in September 2018 after Saudi Food and Drug Authority (SFDA) inspected the manufacturer’s factory in Ras Al Khaimah and found it fell short of complying with GCC regulatory standards.
Julphar officials could not be reached for comment yesterday.
raji@gdn.com.bh
&uuid=(email))