General Requirements
3.1 Responsibility
3.1.1 Initiation of Statutory (Non Voluntary) Recall: Tine Authority shall be
responsible for requesting/ordering a product recall when the registration of
a product is cancelled for safety reasons, or when the product does not
meet regulatory requirements.
In such instances, the Authority shall monitor the effectiveness of the
recalling firm's actions and provide scientific, technical and operational
advice where necessary.
3.1.2 Initiation of Voluntary Recall - It is the recalling firm's sole responsibility to
request and implement the recall process by contacting all companies to
whom the recall products have been distributed and ensuring the physical
removal of the products from the market to the level required.
In such cases prior notice should be given to the Authority.
3.1.3 If the recalling firm's actions are deemed inadequate the Authority will take
appropriate actions to remove the product from sale or use. A firm's recall
does not preclude enforcement actions being taken by the FDA, as
deemed appropriate, either during or following the completion of a recall.
3.2 Product Recall Trigger
Any product / batch(es) not meeting the defined quality standards has to be
recalled from the market. Recall can be of two types; Voluntary Recall and
Statutory Recall.
3.2.1 Voluntary Recall
Voluntary recall can be triggered by any incident that affects the quality, safety
and efficacy of the batch/product in question such as
a) Batch(es) not complying with regulatory specifications during the post
marketing stability study
b) Batch(es) found to be defective during investigation of market complaint.
c) During any failure investigation, if it is observed that the failure under
investigation might have adverse quality impact on already released batch
(e.g. possibility of contamination, mix-up, degradation etc.).
d) If any unusual observation is noted during visual inspection of retention
samples which indicate an impact on quality of the product after investigation.
Procedure to Follow
Not Avaiable
Responsible Institution
No. 17 Indian Ocean Street, Nelson Mandela Avenue, Shiashie
- Email: fda@fda.gov.gh
- Website: https://www.fdaghana.gov.gh/
- GPS: GA-237-7316
- Telephone: (+233)302-233200/ 235100
Relevant Forms to Download
Not Available
Online System
Link Unavailable
Fees/ charges
Not Avaiable
Loading. Please wait....