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The Nationwide Company for Meals and Drug Administration and Management (NAFDAC) is alerting the general public on faulty tetracycline hydrochloride ophthalmic ointment.
The notification is contained in a public alert with No. 04/2023, signed by the Director-Normal of the company, Prof. Mojisola Adeyeye, issued to the Information Company of Nigeria on Tuesday in Abuja.
Adeyeye acknowledged that the World Well being Organisation (WHO) had raised an alarm on batches of the tetracycline hydrochloride ophthalmic ointment USP one per cent for numerous high quality points.
She added that the affected ointment, manufactured by Navi Mumbai-based Galentic Pharma (India) Pvt Ltd, are nonetheless inside legitimate shelf life, quoting WHO as saying “not less than 55 international locations acquired the affected batches, and the producer has initiated a voluntary recall for a number of batches.
“The WHO additionally acknowledged that the producer had indicated that different batches could also be included within the voluntary recall.”
She mentioned that numerous advertising authorisation holders exist for the product and that the product is offered below numerous labelling.
She mentioned “5 worldwide procurers of the product independently performed a visible examination of random samples of inventory available and detected a variety of high quality points.
“The problems reported by every procurer weren’t uniform and different from batch to batch. A few of such points embody the presence of particles, ranging in color, measurement and form on the nozzle within the cap and within the ointment inside every tube.
“Others are black spots and brown splotches on the internal foil layer of the tube, and section separation.
“Tetracycline Hydrochloride Ophthalmic Ointment USP one per is indicated to be used in bacterial blepharitis (purple, swollen, irritated, and itchy eyelids), bacterial conjunctivitis (eye discharge, redness and itching), bacterial keratitis (irritation of the cornea), and trachoma brought on by Chlamydia trachomatis.
“The product is given as therapy for infants and older youngsters and likewise indicated as a safety measure for infants, together with neonates.”
The NAFDAC boss, nonetheless, acknowledged that there’s at the moment no established proof of any hostile occasions from the affected batches of the product, saying that redness and swollen eyes are frequent reactions to common use of tetracycline eye ointment.
She mentioned that there’s at the moment no indication that the above-mentioned high quality points might give rise to hostile occasions that aren’t listed
within the product labelling.
She suggested the general public in possession of the product to discontinue sale or use and submit inventory to the closest NAFDAC workplace.
She additionally urged anybody who suffered any hostile response to hunt immediate medical recommendation.
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