YAZ PLUS (DROSPIRENONE 3,0 mg ETHINYLESTRADIOL 0,02 mg LEVOMEFOLATE CALCIUM 0,451 mg)

YAZ PLUS (DROSPIRENONE 3,0 mg ETHINYLESTRADIOL 0,02 mg LEVOMEFOLATE CALCIUM 0,451 mg)

 

Company name & Address:

 

Registration number

 

Batch number(s)

 

Expiry date

 

Pack size

 

First distributed

 

Re-call Classification

 

Recall date

Date Published
Bayer (Pty) Ltd, 27 Wrench Road Isando, 1600, South Africa  

45/21.8.2/0534

 

WEW96J

 

March 2026

 

28’s

 

9 & 24 November 2023

 

Class II Type A

 

19 November 2024

21 November 2024

 

Brief description of the problem (reason for recall)

This recall is initiated due to a limited number of packs found in retail Pharmacy, with mix-up of the sequence of hormone-containing and hormone-free tablets, wherein some packs had • 24 light orange hormone-free, and • 4 pink film-coated hormone tablets Instead of • 24 pink film-coated hormone tablets and • 4 light orange hormone-free tablets.

 

Advice for health professionals and distributors

Please return all stocks of this batch to DSV Healthcare or the wholesaler/distributor that you purchased it from, for credit.

 

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: 21/11/2024
File Type: www
Category: Product Recall
Unit: General ECTD & human medicines, Regulatory Compliance