PPB - Services

Complaints, Feedback and Enquiry

Medicine quality alert: Class II Medicine Recall of Rapiclav 312.5 DT (Amoxicillin & Potassium Clavulanate)

The Pharmacy and Poisons Board has mandated Sai Pharmaceuticals Limited, Kenya, to initiate an urgent recall of Rapiclav 312.5 DT (Amoxicillin & Potassium Clavulanate) batches; JTQ012001, JTQ012002, JTQ012003, JTQ012004, JTQ012005, JTQ012006, JTQ012007, JTQ012008, JTQ012009, JTQ012010, JTQ012011, JTQ012012, JTQ012013, JTQ012014, JTQ012015, JTQ012016, JTQ012017, JTQ012018, JTQ012019, JTQ012020

From: Pharmacy and Poisons Board

Published: 18/09/2023

Recall Reference Number: REC/2023/14

Recall Classification: Class II

Recall Level: Retail/Facility level

Local Technical Representative: Sai Pharmaceuticals Limited, Kenya.

Manufacturer: Ipca Laboratories Ltd, India

Product name: Rapiclav 312.5 Dispersible Tablets

Active Pharmaceutical Ingredient: Amoxicillin & Potassium Clavulanate

Affected Counties: All

Affected Batches

 

Batch Number

Date of Manufacture

Date of expiry

Pack Size

1.     

JTQ012001

01/03/2024

29/02/2024

100’s

2.     

JTQ012002

01/03/2024

29/02/2024

100’s

3.     

JTQ012003

01/03/2024

29/02/2024

100’s

4.     

JTQ012004

01/03/2024

29/02/2024

100’s

5.     

JTQ012005

01/03/2024

29/02/2024

100’s

6.     

JTQ012006

01/03/2024

29/02/2024

100’s

7.     

JTQ012007

01/03/2024

29/02/2024

100’s

8.     

JTQ012008

01/03/2024

29/02/2024

100’s

9.     

JTQ012009

01/03/2024

29/02/2024

100’s

10.  

JTQ012010

01/03/2024

29/02/2024

100’s

11.  

JTQ012011

01/03/2024

29/02/2024

100’s

12.  

JTQ012012

01/03/2024

29/02/2024

100’s

13.  

JTQ012013

01/03/2024

29/02/2024

100’s

14.  

JTQ012014

01/03/2024

29/02/2024

100’s

15.  

JTQ012015

01/03/2024

29/02/2024

100’s

16.  

JTQ012016

01/03/2024

29/02/2024

100’s

17.  

JTQ012017

01/03/2024

29/02/2024

100’s

18.  

JTQ012018

01/03/2024

29/02/2024

100’s

19.  

JTQ012019

01/03/2024

29/02/2024

100’s

20.  

JTQ012020

01/03/2024

29/02/2024

100’s

Brief description of the problem

The Pharmacy and Poisons Board (PPB) has received several market complaints on quality issues for Rapiclav 312.5 DT tablets (Amoxicillin & Potassium Clavulanate) manufactured by Ipca Laboratories Ltd, India. The reported complaints primarily pertain to a change in the color of the tablets.

In response to these complaints, the PPB conducted a thorough investigation, which revealed that the product did not comply with the market authorization requirements. Consequently, the PPB has instituted a mandated recall of the above-listed twenty batches of Rapiclav 312.5 DT tablets from the Kenyan market.

Action for healthcare professionals

Stop supplying the above batches immediately. Quarantine all remaining stock and await contact from Sai Pharmaceutical Limited, Kenya, who will arrange for the collection of the product.

Action for patients and caregivers

Patients currently prescribed Rapiclav 312.5 DT (Amoxicillin & Potassium Clavulanate)  batches; JTQ012001, JTQ012002, JTQ012003, JTQ012004, JTQ012005, JTQ012006, JTQ012007, JTQ012008, JTQ012009, JTQ012010, JTQ012011, JTQ012012, JTQ012013, JTQ012014, JTQ012015, JTQ012016, JTQ012017, JTQ012018, JTQ012019, JTQ012020 should be contacted by their prescribing healthcare professional. This is because you require a review with your prescribing healthcare professional to discuss alternative treatment options.

Further Information

For inquiries about consignments of the impacted batches, please contact Sai Pharmaceuticals Limited at: info@saipharm.com or sales@saipharm.com. or via telephone: tel:+254-20-4454301/2/3, tel:+254-733-741-911, tel:+254-721-243-322

Promptly report any cases of adverse events and suspected substandard and falsified products to the nearest healthcare facility or through the following channels:

For any further information please contact the post-marketing surveillance unit at the Pharmacy and Poisons Board by email: pms@ppb.go.ke

Download document

Medicine quality alert: Class II Medicine Recall of Rapiclav 312.5 DT (Amoxicillin & Potassium Clavulanate)