The Pharmacy and Poisons Board (PPB) of Kenya has issued a public alert announcing the voluntary recall of S-PRAZO (Esomeprazole Magnesium Delayed-Release Capsules 40mg), Batch No SPZ-302, manufactured by Laborate Pharmaceutical India Limited.
In the notice issued on August 20, the board explained that the recall follows complaints about packaging mix-ups, where some boxes contained both S-Prazo Capsules and Donystatin Tablets.
“The product batch is being recalled following a market complaint regarding mix-up of blister strips; some boxes were found to contain two different blister strips, i.e. S-Prazo Capsules and Donystatin Tablets, within the same outer carton,” said the PPB.
As a result of the packaging mix-up, the board has urged all healthcare professionals, pharmaceutical outlets, healthcare facilities, and the public to immediately cease distribution and return the affected products to their suppliers or nearest healthcare facilities.
“The Board advises all pharmaceutical outlets, healthcare facilities, healthcare professionals and members of the public to STOP further distribution, sale, issuing or use of the product batch and return the specified product batch to their nearest healthcare facility or respective suppliers.”
Details of the Recalled Drug
Prazo 40 MG Tablet is an anti-ulcer medicine, used to treat various stomach and intestinal conditions caused by exessive stomach acid production.
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These conditions include peptic ulcers (open sores on the walls of the stomach, small intestine, and food pipe), erosive esophagitis (swelling of the food pipe), and gastroesophageal reflux disease (a condition where the stomach acid flows back into the food pipe).
Prazo 40 MG Tablet reduces excess acid production in your stomach and relieves the symptoms such as heartburn, inability to swallow food, stomach pain, and vomiting.
The drug also shows side effects like nausea, vomiting, headache, stomach pain, watery stools, and dizziness, these side effects are however mild and usually subside by themselves.
Donystatin Tablets on the other hand is an antifungal drug used to treat yeast or fungal infections in the stomach or intestines.
Kenyans Urged to Report Any Issues Related to the S-PRAZO
Additionally, the Pharmacy and Poisons Board reiterated their commitment to safeguarding public health and emphasized the importance of reporting any suspected substandard medicines or adverse reactions through their official communication channels.
“The Board remains committed to protecting the health of the public and encourages the public to promptly report any suspected cases of sub- standard medicines or adverse drug reactions,” said the Board.
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Members of the public have been advised to report any concerns regarding the medicines via their website, the USSD code *271#, or download the mPvERS mobile app available on both Android and iOS devices.
Additionally, reports can be submitted via email at [email protected] or [email protected], and for urgent inquiries, the Board can be reached directly at 0795 743 049.
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