Recall of Pharmacy Action Dry Cough Relief

HPS Pharmacies wish to give notice that Generic Health, in consultation with the Therapeutic Goods Administration (TGA), has initiated a drug recall for Pharmacy Action Dry Cough Relief oral liquid as follows:

Pharmacy Action Dry Cough Relief
Pholcodine 1mg/mL
ARTG 189867 

This recall has been initiated in response to a safety concern with the active ingredient and affects all batches.

Safety concerns around pholcodine have been highlighted following the recent recommendation of the European Medicines Agency to revoke marketing authorisation for pholcodine-containing medicines in Europe. This is based on data indicating that use of pholcodine in the 12 months before general anaesthesia with neuromuscular blocking agents (NMBA) is a risk factor for developing an anaphylactic reaction to NMBAs.

It is worth noting that the evidence supporting the efficacy of pholcodine is limited and therapeutic alternatives are available for managing dry cough.

Please inspect your stock and quarantine all affected products. If HPS Pharmacies provide imprest management services to your facility, an HPS representative will inspect all stock stored in the designated imprest areas at the earliest opportunity. All affected products will be quarantined for return to the supplier, and HPS Pharmacies will arrange for replacement stock as soon as possible. An HPS Pharmacies staff member will contact senior medical and nursing staff if there is an immediate impact to your facility.

Retain this notice in a prominent position, including in other related business units for one month. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact Generic Health on (03) 9809 7900 or your pharmacist at HPS Pharmacies.

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