The National Agency for Food and Drug Administration and
Control (NAFDAC) has alerted Nigerians to a defective tetracycline
hydrochloride ophthalmic ointment.
In a public alert signed by Mojisola Adeyeye, NAFDAC
director general, the agency said the World Health Organisation (WHO) had
raised an alarm on batches of the tetracycline hydrochloride ophthalmic ointment
USP one percent for various quality issues.
She said the ointment, manufactured by India-based Galentic
Pharma (India) Pvt Ltd, is still within valid shelf life.
Adeyeye quoted WHO as saying that at least 55 countries
received the affected batches, and the manufacturer has initiated a voluntary
recall for several batches.
“The WHO also stated
that the manufacturer had indicated that other batches may be included in the
voluntary recall,” the statement reads.
“Five international procurers of the product independently
conducted a visual examination of random samples of stock on hand and detected
a range of quality issues.
“The issues reported by each procurer were not uniform and
varied from batch to batch. Some of such issues include the presence of
particles, ranging in colour, size, and shape on the nozzle in the cap and in
the ointment inside each tube.
“Others are black
spots and brown splotches on the inner foil layer of the tube, and phase
separation.
“Tetracycline Hydrochloride Ophthalmic Ointment USP one
percent is indicated for use 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.
“The product is given as treatment for infants and older
children and also indicated as a preventive measure for infants, including
neonates.”
Adeyeye said there is currently no established evidence of
any adverse effects from the affected batches of the product, saying that
redness and swollen eyes are common reactions to the general use of
tetracycline eye ointment.
She advised the public in possession of the product to
discontinue sale or use and submit stock to the nearest NAFDAC office.
She also urged anyone who suffered any adverse reaction to
seek prompt medical advice.
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