Demetrin 10mg (prazepam)

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27 Apr Demetrin 10mg (prazepam)

Posted at 12:57h in by

Company name & Address Registration number Batch number Expiry date Pack size                                                                First distributed  

Re-call Classification

  

Re-call Date
 

Pfizer Laboratories (Pty) Ltd, 85 Bute Lane, Sandton South Africa

  

G/2.6/188

                        DT3236  

28 Feb-2023

                                                                          100’s  

21 July-2020

  

Class II Type B

 

 4 July 2022

 

Reason for recall

The recall is due to out of specification results for dissolution during stability studies, Pfizer Laboratories (Pty) Ltd in South Africa took the decision to initiate a voluntary recall on Demetrin 10 mg, batch DT3236.

 

Advice to HCPs/Distributors/Public:

The company requested the return of all stock of the affected batch to the supplying distributor/wholesaler for full credit without delay.

 

Proposed action taken and its urgency: SAHPRA approved recall letter distributed to all distribution points, recall 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: 04/07/2022
File Type: www
Category: Product Recall
Unit: General ECTD & human medicines, Regulatory Compliance