THE WORLD Health Organization (WHO) has announced the recall of an eye drug administered on children from global markets.
Galentic Pharma Pvt Ltd, Maharashtra, India, manufactured the tetracycline hydrochloride ophthalmic ointment USP 1% drug.
In a statement on its website on Wednesday, February 22, the WHO said though the batches were yet to expire, they showed some unusual features when sampled in different countries.
According to the WHO, the manufacturers initiated a voluntary recall for several batches of the product. They also indicated that they might include other batches in the recall.
The WHO said there was no established evidence of any adverse events from the affected batches yet.
Five international procurers of the product independently conducted visual examination of random stock samples on hand. They detected a range of quality issues with the random samples of the product batches.
“They observed particles ranging in colour, size and shape on the nozzle, in the cap and the ointment inside each tube, black spots and brown splotches on the inner foil layer of the tube, and phase separation.
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“These issues were not uniform and varied from batch to batch and as reported by procurer to procurer.”
The product is used in bacterial blepharitis (red, swollen, irritated, and itchy eyelids), bacterial conjunctivitis (eye discharge, redness, and itching), bacterial keratitis (inflammation of the cornea), and trachoma (caused by Chlamydia trachomatis).
It is given as a treatment for infants and older children.
If not recalled, risks of using the product include redness and swollen eyes, the WHO noted.
The product has been supplied in bulk and as a component of various medical kits by some international organisations providing humanitarian assistance.
The WHO assured that the agencies and organisations would be contacted for further information and guidance.
At least 55 countries received the affected batches.
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“Out of abundance of caution, WHO advises regulatory authorities, healthcare professionals, and the public to detect and remove from circulation all batches of tetracycline hydrochloride ophthalmic ointment USP 1%.”
The organisation promised increased surveillance and diligence within the supply chains of countries and regions likely to be affected by the affected batches of the product.
It then urged the public: “If you are in possession of any of the affected products, WHO recommends out of abundance of caution not to use them. If you, or someone you know, has or may have used the affected product, or suffered an adverse reaction or unexpected side-effect after use, you are advised to seek immediate medical advice from a qualified healthcare professional who should, in turn, report the incident to the national regulatory authority and/or national pharmacovigilance centre.
“National regulatory/health authorities are advised to immediately notify WHO if any of the affected batches of the product are identified in their respective country. Please contact WHO via [email protected].”
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