Medicine Quality Alert: Class II Recall of Oralex C Mouthwash Batch No. L220077
The Pharmacy and Poisons Board has mandated Krishna Chemist Limited to initiate the urgent recall of Oralex C Mouthwash Batch No.L220077
From: Pharmacy and Poisons Board
Published: 18/09/2023
Recall Reference Number: REC/2023/013
Recall Classification: Class II
Recall Level: Retail/Facility level
Local Technical Representative: Krishna Chemist Limited
Manufacturer: Curis Lifesciences PVT. Ltd
Product name: Oralex C Mouthwash
Active Pharmaceutical Ingredient: Chlorhexidine Gluconate & Benzydamine Hydrochloride mouthwash
Affected Counties: All
Affected batch
Batch Number | Date of Manufacture | Date of Expiry | Pack Size |
L220077 | 06/2022 | 05/2025 | 200 ml |
Brief description of the problem
The product is being recalled following out-of-specification results. The product failed to comply with the specifications on the description as per market authorization requirements.
Action for healthcare professionals
Stop supplying the above batch immediately. Quarantine all remaining stock and await contact from Krishna Chemist Limited, Kenya, who will arrange for the collection of the product.
Action for patients and carers
Patients currently prescribed Oralex C Mouthwash Batch No.L220077 should be contacted by their prescribing healthcare professional. The patients should continue taking other batches of the product other than the impacted batches and as prescribed by the healthcare professional.
Further Information
For inquiries about consignments of the impacted batches, please contact Krishna Chemist Limited at: regulatory@krishnachemists.com or Tel: +254 722 366 988, +254 714 714 178, +254 715 946 380
Promptly report any cases of adverse events and suspected substandard and falsified products to the nearest healthcare facility or through the following channels:
- https://pv.pharmacyboardkenya.org/users/mpublic
- USSD code at *271#
- Email pv@ppb.go.ke or pms@ppb.go.ke
- Telephone No. 0795743049
- Mobile application: mPvERS both Android and iOS
For any further information please contact the Pharmacy and Poisons Board by email: pms@ppb.go.ke
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Medicine Quality Alert: Class II Medicine Recall of Oralex C Mouthwash Batch No. L220077