Fertomid-50 Tablets (Clomiphene Citrate 50 mg)

Fertomid-50 Tablets (Clomiphene Citrate 50 mg)

 

Company name & Address

 

Registration number

 

Batch number(s)

 

Expiry date

 

Pack size

 

First distributed

 

Re-call Classification

 

Recall date

 

Published date

Cipla Medpro (Pty) Ltd

Parc du Cap, Building 9, Mispel Street, Bellville, 7530

31/18.8/0625 GH21051 October 2025

 

10 tablets 08 March 2023 Class II Type C 03 March 2025 10 March 2025

 

Brief description of the problem (reason for recall)

An out-of-specification result for related substances observed during stability testing of batch GH21051.

 

Advice for health professionals and distributors

We request that you refrain from selling or dispensing Fertomid-50 Tablets, Batch No. GH21051. Please return all remaining stock to your supplying warehouse or distributor with immediate effect. Cipla Medpro (Pty) Ltd will collect all your stock which will be credited / replaced.

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: 10/03/2025
File Type: www
Category: Product Recall
Unit: General ECTD & human medicines, Regulatory Compliance