By Morara Kebaso
A pharmaceutical distributor has initiated a mandate recall for a mouthwash citing deficiency in meeting the established market criteria.
Krishna Chemists Limited, dealers in pharmaceuticals, surgical, and laboratory supplies recalled the Oralex C Mouthwash Batch No. L220077 Class II with the knowledge of the Pharmacy and Poisons Board (PPB) and gave chemists who have stocked the mouthwash up to next week to return the said consignment.
“A mandated recall for Oralex C Mouthwash Batch No.L220077 has been initiated. The reason for the same is that there were some Out of Specification (OOS) results that have been detected,” Dr. Apurva Shah, Krishna Chemists Ltd, Regulatory Affairs Pharmacist wrote in an urgent memo.
In a memo sent to the pharmacist in charge at BelEa Pharmacy Limited, which has already stocked the mouthwash, Dr. Shah asked them to examine their inventory and quarantine immediately, subject to return to Krishna’s premises by October 16, 2023.
BelEa Pharmacy Limited is also required to indicate the Krishna Chemists Invoice number for replacement with a new batch or issuing of a credit note of the same.
“In addition, if you may have further distributed this product, please identify your customers, and notify them at once of this product recall,” Dr. Shah wrote.
The said product recall is up to the wholesale and retail level only.
“Please return a duplicate copy of this letter by signing, stamping, and recording the name of the responsible person,” the memo further reads.
Dr. Shah also revealed that the recall was made with the knowledge of the PPB.
“And for further clarification on this matter, please contactregulatory@krishnachemists.com
Last month, the PPB recalled an oral medicine used to relieve pain and fever in children.
Dr Fred Siyoi, the chief executive of the regulator, said the paracetamol oral solution called Tamedol had been banned.
Tamedol is manufactured by a Kenyan pharmaceutical company, Biopharma Limited, and becomes the ninth in a growing list of medicines so far recalled by the regulator this year alone.
Dr Siyoi said the regulator initiated the revocation process after receiving a series of complaints from customers on the quality of several batches of Tamedol.
“In response to these concerns, the PPB, upon investigations, indeed confirmed that the product failed to meet the prescribed market authorisation requirements and has initiated a mandatory recall of the product,” said Dr. Siyoi.
Effectively, this halted the sale of Tamedol, and PPB urged the public to surrender any stocks they had bought to the nearest health facility.
Dr. Wairimu Mbogo, a board member of Pharmaceutical Society of Kenya (PSK) and also head of Commercial Operations at Meraky Healthcare Limited welcomed the move, saying this shows the sector is able to regulate itself.
“Sometimes the recalls are initiatedby the manufacturer. But overall this demonstrates the capacity the sector has in self-regulation,” she told Health Business Magazine.
