Medicine Quality Alert: Class II Recall of DTO (Ornidazole/Ofloxacin) tablets, Batch Number DDBR2201
Two Kay Chemicals Limited is implementing an urgent voluntary recall of DTO (Ornidazole/Ofloxacin) Batch number DDBR2201 due to color change.
From: Pharmacy and Poisons Board
Published: 17th August 2023
Recall Reference Number: REC/2023/009
Recall Classification: Class II
Recall Level: Retail/Facility level
Local Technical Representative: Two Kay Chemicals
Manufacturer: Ms. Coral Laboratories Ltd, India
Product name: DTO Tablets
Active Pharmaceutical Ingredient: Ornidazole/Ofloxacin
Affected Counties: All
Affected batch
Batch Number | Date of Manufacture | Date of expiry | Pack Size |
DDBR2201 | 05/2022 | 04/2025 | 10’S |
Brief description of the problem
Two Kay Chemicals Limited has initiated an urgent recall of DTO (Ornidazole/Ofloxacin) due to market complaints regarding a quality defect in product batch number DDBR2201. The nature of the complaint is a color change.
The Pharmacy and Poisons Board conducted an investigation and concluded that the product was out of specification (OOS). Quality control analysis confirmed that the product failed to meet the specifications of description.
Action for healthcare professionals
You are advised to stop supplying the above batches and immediately quarantine all the remaining stock of the product. Two Kay Chemicals Limited will contact you to arrange the return of the impacted batches.
Action for patients and carers
Patients currently prescribed the impacted batches of DTO (Ornidazole/Ofloxacin) should seek advice from healthcare providers. This is because you require a review with your prescribing healthcare professional to discuss alternative treatment options.
Further Information
For stock enquiries please contact Two Kay Chemicals Limited at: twokay@bidii.com
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 Recall of DTO (Ornidazole/Ofloxacin) tablets, Batch Number DDBR2201