PROTA 50 mg/ 5 ml (Protamine Sulphate – Ampoules for IV injection)

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27 Apr PROTA 50 mg/ 5 ml (Protamine Sulphate – Ampoules for IV injection)

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PROTA 50 mg/ 5 ml (Protamine Sulphate – Ampoules for IV injection)

Company name &

Address

  

registration number

  

Batch number

  

Expiry date

  

Pack size

  

First distributed

  

Re-call Classification

  

Re-call Date
 

Equity Pharmaceutica ls (Pty) Ltd, 100 Sovereign Drive, Route 21 Corporate park, Irene, Pretoria, South Africa, 0157

  

N/A (Section 21, Unregistered)

 IPTAA1203 31.12.2023 25’s  

11/2020

  

Class II Type B

 26 May 2022

 

Reason for recall

The product was being recalled due to quality defect: Floaters that look like mould were found inside a few number of ampoules.

 

Advice to HCPs/Distributors/Public:

As a safety precautionary measure, due to affected units found, Equity Pharmaceuticals (Pty) Ltd recommends that healthcare providers should immediately discontinue the use of PROTA injection and to return all units of PROTA to Equity Pharmaceuticals (Pty) Ltd. and send an email to section21@equitypharma.co.za to arrange for upliftment and credit. They are also advised to retain the recall letter in a prominent position for one month.

 

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: 26/05/2022
File Type: www
Category: Product Recall
Unit: General ECTD & human medicines, Regulatory Compliance