JANUMET 50/850mg and JANUMET 50/1000mg (50mg of Sitagliptin with 850mg of Metformin Hydrochloride AND 50mg of Sitagliptin with 1000mg of Metformin Hydrochloride)

Reason for recall

The products are being re-called due to quality defect; the company initiated a recall because the above batches are not in compliance with the registered requirements for the South African market, as follows:

1. The incorrect artwork for both the packaging insert and the unit carton. The languages are in English and Portuguese and should be in English and Afrikaans per the local market requirements.
2. The packs do not contain a Patient Information Leaflet.
3. The material for the primary packaging is not registered for the local market.
4. The sold packs do not have the SA registration on the artwork

Advice to HCPs/Distributors/Public:

The company has requested the customers to refrain from selling any of the affected batch(s) of the JANUMET 50/850 mg and 50/1000mg packs and return to them to their supplying warehouse / distributor with immediate effect.

Proposed action taken and its urgency: The recall has id initiated; a SAHPRA approved recall letter to be distributed to all distribution points

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.