Withdrawal of Pholcodine products
On Tuesday 14th March, the GHA actioned the withdrawal of Pholcodine on the basis of the advice received from the MHRA (Medicines and Healthcare products Regulatory Agency) EL (23) A/09.
The message was received by the GHA at 12:25pm and communicated to all community pharmacies by 12:30 pm to withdraw this product from sale in its many forms. The GHA pharmacy team withdrew stock from wards and departments and the main dispensary over the next 2 hours. All withdrawn stock has been quarantined in the GHA Pharmacy store and will be returned to the supplier.
Pholcodine has been withdrawn in a number jurisdictions, including the EU and Australia, because of concerns that it can produce a very rare event of anaphylaxis when a patient who has taken this in the last 12 months is exposed to neuromuscular blocking agent (NMBA).
The Director General Professor Patrick Geoghegan takes any risks to the people of Gibraltar very seriously and is pleased that the GHA’s quick action ensured that the public was not put at risk.
Any withdrawn Pholcodine products on this list should not be used and taken to a pharmacy for safe disposal:
Company: The Boots Company PLC
Product name
Boots Night Cough Relief Oral Solution, PL 00014/0230
Boots Dry Cough Syrup 6 Years+, PL 00014/0523
3.
Boots Day Cold & Flu Relief Oral Solution, PL 00014/0565
Company: Thornton & Ross Limited
Product name
Cofsed Linctus, PL 00240/0097
2.
Care Pholcodine 5mg/5ml Oral Solution Sugar Free,PL00240/0101
Galenphol Linctus, PL00240/0101
4.
Galenphol Paediatric Linctus, PL00240/0102
5.
Galenphol Strong Linctus, PL 00240/0103
6.
Covonia Dry Cough Sugar Free Formula, PL 00240/0353
Company: Bell Sons & Company (Druggists) Limited
Product name
1.
Pholcodine Linctus Bells Healthcare 5mg Per 5ml Oral Solution, PL 03105/0059 2.
Numark Pholcodine 5mg per 5ml Oral Solution, PL 03105/0059
3.
Well Pharmaceuticals Pholcodine 5mg per 5ml Oral Solution, PL 03105/0059
4.
Superdrug Pholcodine Linctus BP,PL03105/0059
5.
Strong Pholcodine Linctus BP, PL 03105/0060
Company: Pinewood Laboratories Limited
Product name
Pholcodine Linctus BP,PL04917/0002
2.
Strong Pholcodine Linctus BP, PL 04917/0005
Company: LCM Limited
Product name
Pholcodine Linctus, PL 12965/0030
Company: Glaxosmithkline Consumer Healthcare (UK) Trading Limited
Product name
Day & Night Nurse Capsules, PL44673/0068
Day Nurse Capsules, PL 44673/0069
3. Day Nurse, PL 44673/0075
