The Food and Drugs Authority (FDA) has alerted healthcare professionals and consumers, not to distribute supply, or purchase any Hydrocortisone Injection B.P 100mg.
Hydrocortisone injection is used to treat severe allergic reactions. It is also used in the management of multiple sclerosis (a disease in which the nerves do not function properly), lupus (a disease in which the body attacks many of its own organs), gastrointestinal disease, and certain types of arthritis.
The said product is labelled Hydrocortisone Sodium Succinate Injection B.P 100mg, batch number 5AE01007, manufactured by Ambica Pharma Sales, India with expiring date 09/2018.
A statement signed by Mrs Delese A.A. Darko, the Chief Executive Officer of FDA and copied to the Ghana News Agency on Monday, said the FDA laboratory analysis of the product found that there was a lack of uniformity of content and related concerns, which makes it unfit and unsafe for a purpose.
It said the Authority had commenced the process of immediate withdrawal of the product from health facilities and pharmaceutical suppliers that may have stocks, and hereby, directed all such facilities to immediately check their medical suppliers, quarantine any affected product, labelled as stated above and return them to the suppliers or the FDA.
The statement assured the public that the FDA would continue to do all within its mandate to ensure the safety and efficacy of all products found in the Ghanaian market.
“Healthcare professionals and suppliers of pharmaceutical products are encouraged to obtain any medications they administer or provide to consumers/the general public, from reliable sources that adhere to proper quality standards,” it said.
The FDA urges the public and healthcare professionals to report all adverse reactions, quality problems or any practice suspected to be against public health and safety to any of the hotlines: 0299802932, 0299802933; short code – 4015 (on all networks except GLO)