Q444 · What is a “drug recall”? What should I do if…

Q444 · Category I: Renewals, changes and penalties for non-compliance (Q401-Q450)

A medicine recall is the withdrawal from the supply chain of one or more batches of medicines distributed on the market, usually because a quality, safety or efficacy issue has been identified or suspected. If, as a licence holder, you are instructed by the Department of Health or decide yourself to initiate a recall, you must immediately implement a pre-established recall procedure. This includes immediately stopping the distribution of affected batches; notifying all downstream customers who received them, such as pharmacies and hospitals; arranging for the medicines to be returned by customers; segregating the returned medicines and keeping records; and submitting a detailed recall report to the Department of Health.

📘 Regulatory basis

The Good Distribution Practice (GDP) for Wholesale Dealers in Medicines requires all licensees to establish an effective Standard Operating Procedure (SOP) for medicine recalls.

📗 Drew Tang's recommendations

Effective recall capability depends on accurate day-to-day batch management and distribution records. We recommend that clients conduct mock recalls regularly to test and optimise their traceability systems and communication processes, ensuring they can respond quickly and effectively when an actual recall occurs.

📕 Risk notice

Failure to carry out an effective recall is an extremely serious breach because it directly affects the ability to control public health risks. This will not only invite severe disciplinary action but also completely destroy the market’s confidence in your products and brand.

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang

Business Manager Tang Shangyong (Drew Tang) will review your products, operating model, licence type and preparation requirements with you one-to-one. The precise service scope is confirmed in writing; pharmaceutical duties are carried out by legally qualified personnel, and approvals are determined by the competent authorities.

What is a “drug recall”? What should I do if my product needs to be recalled?

Plan Your Hong Kong Pharmaceutical Licensing Project with Drew Tang