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Withdrawal of Pholcodine products – 156/2023

By March 17, 2023 No Comments

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 All withdrawn stock has been quarantined in the GHA Pharmacy store and will be returned to the supplier.

Pholcodine has been withdrawn in a number jurisdictions, including the EU and Australia, because of concerns that it can produce a very rare event of anaphylaxis when a patient who has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Any withdrawn Pholcodine products on this list should not be used and taken to a pharmacy for safe disposal: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

  1. Boots Night Cough Relief Oral Solution, PL 00014/0230
  2. 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

  1. Cofsed Linctus, PL 00240/0097
  2. Care Pholcodine 5mg/5ml Oral Solution Sugar Free, PL 00240/0101
  3. Galenphol Linctus, PL 00240/0101
  4. Galenphol Paediatric Linctus, PL 00240/0102
  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, PL 03105/0059
  5. Strong Pholcodine Linctus BP, PL 03105/0060

Company: Pinewood Laboratories Limited

Product name

  1. Pholcodine Linctus BP, PL 04917/0002
  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

  1. Day & Night Nurse Capsules, PL 44673/0068
  2. Day Nurse Capsules, PL 44673/0069
  3. Day Nurse, PL 44673/0075