Market Complaints

Drug Product Recall in Pharmaceutical Industry

Drug Product Recall in Pharmaceutical Industry

Byipharmacist

  If the FDA or a manufacturer finds that a marketed product presents a threat or a potential threat to consumer safety, that product may be recalled or sought for return to the manufacturer from its depth of distribution. The pharmaceutical manufacturer is legally bound to report serious unlabeled adverse reactions to the FDA through…

How to Correctly Manage Quality Defects and Recalls?
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How to Correctly Manage Quality Defects and Recalls?

Byipharmacist

In Europe, The EMA coordinates the assessment of reports of product quality defects of centrally authorized medicines.   Medicinal products with a quality defect are not of the correct quality as defined by their marketing authorization.   It is important to report these defects in a timely manner because sometimes it is necessary to implement…