26 Oct 2010
Subsequent investigation by the Department of Health (DH) unfolded that drug manufacturer Neochem Pharmaceutical Laboratories Ltd (Neochem) had manufactured and distributed another two products during July and August when it did not have valid licence. The DH has today (October 26) ordered a recall of the affected batches.
This is in addition to the recall of 42 batches of 37 Neochem products announced on October 22.
Production and distribution of the latest two batches of products were revealed by the DH when scrutinising the manufacturer's records during further investigation. The latest recall was directed as the safety, efficacy and quality of the batches of products cannot be guaranteed.
The affected products, Chlordiazepoxide 2.5mg Capsule (HK-27469, Batch No. 100492) and Chlordiazepoxide 10mg Capsule (HK- 27481, Batch No. 100493), were indicated for short-term treatment of anxiety.
Both were dangerous drugs and only supplied to private doctors. Neochem will recall the two batches from the doctors direct.
A DH spokesman urged patients who use the products to stop using them immediately.
“They should contact their healthcare professionals if in doubt,” he said.
Neochem has set up a hotline, 3427 3525, to answer enquiries during office hours. DH will closely monitor progress of the recall.
Neochem's manufacturer licence was suspended by the Pharmacy and Poisons (Manufacturers Licensing) Committee (the Committee) of the Pharmacy and Poisons Board in April 2010 and was not fully restored until September after it had satisfied the Committee that it was in compliance with Good Manufacturing Practices (GMP).
The DH is consulting the Department of Justice on possible legal actions. The issue will also be discussed in the Committee’s next meeting for possible disciplinary actions.