Deplatt Tablets (Clopidogrel 75 mg)

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27 Apr Deplatt Tablets (Clopidogrel 75 mg)

Posted at 13:24h in by

 

Company name & Address:

  

Registration number

  

Batch number(s)

  

Expiry date

  

Pack size

  

First distributed

  

Re-call Classification

  

Recall date
Trinity Pharma (Pty) Ltd, 3 Gwen Lane Fourth Floor Sandton  

45/8.2/1031

  

BT40J001

  

December 2023

  

30’s

  

28 June 2022

  

Class II Type C

  

02 November 2023

 

Reason for recalls

This recall is initiated due to an out of specification result for the assay test at 18 months timepoint at long term storage conditions i.e., 25°C/ 60%RH.

 

Advice to HCPs/Distributors/Public

We request that you quarantine and refrain from selling any of the affected batch BT40J001 of Deplatt tablets and return them to your supplying warehouse or distributor with immediate effect for reimbursement.


Proposed action taken and its urgency: A SAHPRA approved recall letter was distributed to all distribution points and the recall process was initiated.

 

Reporting side effects

Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.

Download latest version
Version: 1
Date Updated: 02/11/2023
File Type: www
Category: Product Recall
Unit: General ECTD & human medicines, Regulatory Compliance