The Food and Drugs Authority (FDA) seems to be hot over its decision to recall immune booster drug COA FS.
The question on the minds of many Ghanaians is why the product was approved by the FDA months ago but has now been declared as unwholesome and why the entire product is being recalled and not a particular batch.
Speaking in an interview on Peace FM's morning show 'Kokrokoo', James Lartey, the Director of Communications of the FDA explained why the entire product was recalled.
He said even though the FDA has not condemned the product, a particular batch could be recalled because of inconsistencies.
"Under normal circumstances, you do a batch recall but it has become necessary because at the facility asking questions about the batch; the reply was very bad. Questions that were posed to them, they were not able to answer it and so due to the inconsistency, we had to recall all," he explained.
FDA Approval
Answering to why the product was recalled when it was approved by the FDA, he said: "when the product comes on the market it is up to us to ensure that it has been approved . . . what we are talking about has nothing to do with the functionality of COA FS product; not about efficacy but its safety. But in the light of production, we realized there is contamination. Even the one that is contaminated is an approved product"
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