Amedin 5mg and 10mg
Summary
Date Recall was issued:
Product Name:
Manufacturer:
Recalling Firm:
Batch(es):
Manufacturing Date:
Expiry Date:
Reason for Recall:
6th September 2023
Amedin 5mg and 10mg
E.P DIS CFAO Healthcare
Gokals Laborex
B20554
March 2023
February 2024
This recall has been necessitated as a result of ongoing stability analysis by the manufacturer which confirms that the related substance test carried out on the product is out of specification. This makes the product substandard and therefore not recommended for its intended use.
Announcement
This recall is necessitated as a result of warehouse market surveillance conducted at the warehouse. Actual product specification is a powder for oral suspension. The affected batches were caked and not free flowing. This makes the product substandard and therefore not recommended for its intended use.
