FDA recalls ‘unfit and unsafe’ India-made injection product

The Food and Drugs Authority (FDA) says it is immediately withdrawing Hydrocortisone Injection from health facilities and pharmaceutical suppliers for safety reasons.

The Hydrocortisone Sodium Succinate Injection B.P 100mg is manufactured by Ambica Pharma Sales, India, with batch number 5AE01007.

The Authority has asked all health care professionals and consumers not to distribute, supply, use or purchase the product.

“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 purpose,” a statement issued by FDA said.

All health facilities and pharmaceutical companies have been directed to immediately check their medical supplies, quarantine product and return them to the suppliers or the Food and Drugs Authority.

The Authority admonished health care professionals and suppliers of pharmaceutical products to obtain any medications they administer or provide to consumers/the general public, from reliable sources that adhere to proper quality standards.

Assuring the general public that it will continue to ensure the safety and efficacy of all products found in the Ghanaian market, the FDA also appealed to the public to report all adverse reactions, quality problems or any practice suspected to be against public health and safety to any of the following contacts: Hotlines: 0299802932, 0299802933 and Short Code: 4015 (On all networks except GLO).

Source: 3news.com | Ghana

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