Class 2 Drug Alert (Action within 48 hours): Pinewood Laboratories Limited - Boots Heartburn Relief Peppermint Flavour, Peptac Peppermint Liquid, Peptac Liquid Aniseed Flavour - EL (09)A/30

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Dear Healthcare Professional,

Boots Heartburn Relief Peppermint Flavour	PL 04917/0027
Peptac Peppermint Liquid (Ivax Pharmaceuticals UK)	PL 04917/0027
Peptac Liquid Aniseed Flavour (Ivax Pharmaceuticals UK)	PL 04917/0021

(Oral suspensions containing sodium alginate 250mg, sodium bicarbonate 133.5mg and calcium carbonate 80mg per 5ml)

Information for consumers Pinewood Laboratories Limited is carrying out a precautionary recall on three medicines, Boots Heartburn Relief Peppermint Flavour, Peptac Peppermint Liquid (Ivax Pharmaceuticals UK) and Peptac Liquid Aniseed Flavour (Ivax Pharmaceuticals UK) due to a low-level bacterial contamination detected in three batches. The contamination could cause the medicine to spoil and change the smell from peppermint/aniseed to antiseptic. It must be stressed that these recalls are purely precautionary. Health risks are extremely low and there is currently no evidence of harm. People who have used, or have this product at home, do not need to worry. Those with suppressed immune systems, such as patients on chemotherapy, the risk of infection from this contamination cannot be ruled out. If people have any worries or suspected side effects, then they should contact their doctor.

Boots Heartburn Relief Peppermint Flavour

Batch Number	Expiry Date	Pack Size	First Distributed
41808	31/12/2010	500ml bottle	June 2009

Peptac Peppermint Liquid (Ivax Pharmaceuticals UK livery)

Batch Number	Expiry Date	Pack Size	First Distributed
41808	31/12/2010	500ml bottle	February 2009
41957	31/01/2011	500ml bottle	March 2009

Peptac Liquid Aniseed Flavour (Ivax Pharmaceuticals UK livery)

Batch Number	Expiry Date	Pack Size	First Distributed
41757	30/11/2010	500ml bottle	March 2009

Pinewood Laboratories Limited are recalling the above lots due to a low-level microbial contamination detected in a small number of samples from these batches. The contamination causes spoilage of the product and a phenolic or antiseptic smell. The products should smell of peppermint or aniseed.

The microbial contamination is not likely to be harmful to normally healthy consumers. However, if these products are being used by patients with suppressed immune systems, such as patients on chemotherapy, the risk of infection and other adverse reactions cannot be ruled out. General Practitioners or Pharmacists receiving enquiries from such patients are requested to give professional advice and refer to the responsible treatment centre where necessary.

For Medical Information enquiries, please call Pinewood Laboratories Limited on 00353 52 6136253

For any other queries relating to the Boots product, please contact Central Customer Care on 08450 708090

For all queries relating to stock of the Ivax products please contact: Jane Booth, Customer Liaison manager, Teva UK Limited on Freephone 0800 590502

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. Primary care Trusts are asked to forward this to relevant clinics and to General practitioners and Community Pharmacists for information.

Yours faithfully

Alison Bunce
Pharmaceutical Assessor, DMRC

MHRA Distribution (further recipients by cascade):

Regional Contacts for NHS Trusts and Provider Units
Chief Pharmacists: England, Scotland, Wales, Northern Ireland
Prison Health Policy Unit (DH)
Chief Pharmacists: Jersey, Guernsey, Alderney, Sark, Isle of Man, Gibraltar
Special Hospitals
Healthcare Commission for distribution to Independent Health Care Establishments
Primary Care Trusts (England)