Coryx Throat Spray (Benzocaine and chlorhexidine gluconate solution 20 %)

Coryx Throat Spray (Benzocaine and chlorhexidine gluconate solution 20 %)

Company name & Address:  

registration number

 

Batch number(s)

 

Expiry date

 

Pack size

 

First date of release

 

Re-call Classification

 

Re-call Date

 

Cipla Medpro (Pty) Ltd

 

Parc du Cap

Building 9

Mispel Street

Bellville

7530

Telephone number (021) 94
 

 

 W/16.3/58
ZB000156,

ZB000157,

ZB000158,

ZB000159,

ZB000160,

ZB100105,

ZB100107

ZB100172

 

10.2022

10.2022

10.2022

10.2022

10.2022

02.2023

02.2023

03.2023

 

100 ml

04.02.2021

04.02.2021

09.02.2021

09.02.2021

09.02.2021

14 & 15.06.2021

 

21. 06.2021

 

Class I Type A

 

15 June 2022

 

Reason for recall

Cipla Medpro (Pty) Ltd, in collaboration with SAHPRA, is recalling the above-mentioned batches of Coryx Throat Spray.

 

The reason for the Class I Type A product recall is the remote possibility that the spray nozzle may detach from the spray mechanism during use:

The company received two product complaints from two customers (1st customer on 04.06.2021 & 2nd customer on 06.12.2021) who purchased a bottle of Coryx Throat Spray.

Customer 1: The customer complained that the spray nozzle came off and was stuck in his throat, he was not able to remove it and the cap was swallowed. The customer further explained that his throat was damaged trying to remove the cap.

Customer 2: The customer complained that the spray nozzle of the bottle came off while he was using it and he involuntarily swallowed it.

 

Advice to HCPs/Distributors/Public:

All affected stock/ batches should be removed from the client’s inventory with immediate effect and returned via the normal distribution channel. The recall applies to all distribution points i.e. wholesalers throughout the country, hospital services (private as well as state hospitals), retail outlets, doctors, nurses, pharmacists, authorised prescribers and dispensers and individual customers or patients.

Proposed action taken and its urgency: SAHPRA approved recall letter distributed to all the above-mentioned distribution points and an approved press statement released to public. Immediate recall has been initiated.

Media release Publication: eNCA Headline: Cipla recalls batches of Coryx throat spray

Link: https://www.enca.com/business/cipla-recalls-batches-coryx-throat-spray

Media Coverage confirmation: Coryx Throat recall

 

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: 15/06/2022
File Type: www
Category: Product Recall
Unit: General ECTD & human medicines, Regulatory Compliance