FDA alerts public of unsafe Hydrocortisone Injection


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Accra, Sept. 17, GNA – The Food and Drugs
Authority (FDA) has alerted healthcare professionals and consumers, not to
distribute supply, or purchase any Hydrocortisone Injection B.P 100mg.

The 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.

Accra, Sept. 17, GNA – The Food and Drugs
Authority (FDA) has alerted healthcare professionals and consumers, not to
distribute supply, or purchase any Hydrocortisone Injection B.P 100mg.

The 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 un
safe for 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)

GNA


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