Class 2 Drug Alert (Action within 48 hours): Procter & Gamble (Health & Beauty Care) Ltd - Vicks Sinex Micromist - EL (09)A/31

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Dear Healthcare Professional,

Information for consumers Proctor & Gamble (Health & Beauty Care) Ltd is carrying out a precautionary recall on one batch of Vicks Sinex Micromist 15 ml Nasal Spray (batch number 9224028832) at wholesale and pharmacy level. The expiry date is 12 August 2013. This is due to the detection of bacterial contamination during routine testing of a batch in the USA. The UK batch was derived from the same bulk batch as the US batch. No bacterial contamination has been detected in UK packs. Proctor & Gamble is recalling this batch as a precautionary measure while testing is ongoing and the causes are being investigated. It must be stressed that as this is a precautionary measure, health risks are low and there is currently no evidence of harm. The bacteria pose little risk to healthy people. However, the bacteria could cause serious infections for people with weak immune systems, or those with chronic lung conditions, such as cystic fibrosis. If people have any concerns, they should speak to their doctor. They can also call Proctor & Gamble on 0800 555515 for medical information.

 

Batch Number	Expiry Date	Pack Size	First Distributed
9224028832	12/08/2013	15ml Nasal Spray	26 August 2009

Procter & Gamble (Health & Beauty Care) Ltd are recalling the above batch due to the detection during routine testing of microbial contamination in a small amount of product from another batch in the USA which was derived from the same bulk batch (ie prepacked product). The company’s analysis to date shows this problem is limited to a single batch of bulk involving three packed batches, only one of which is a UK batch.

No microbial contamination has been detected in UK packs from batch 9224028832, but the marketing authorisation holder wishes to recall this batch as a precautionary measure whilst testing is ongoing and the causes are being investigated.

We understand that the bacteria identified in the USA samples are Burkholderia cepacia. There have been no reports of illness. However, the bacteria could cause serious infections for individuals with a compromised immune system, or those with chronic lung conditions, such as cystic fibrosis. Burkholderia cepacia poses little medical risk to healthy individuals.

For Medical Information enquiries, please call Procter & Gamble on 0800 555515.

For queries relating to stock return please contact your Wholesaler/Head Office. If further information is required, please contact Procter & Gamble on 0800 555515.

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)