27 Apr 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 |
||||||||
|
|
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.