Dear Healthcare Professional,

Procter & Gamble (Health & Beauty Care) Ltd

Vicks Sinex Micromist                              PL 00129/0133

(Oxymetazoline Hydrochloride 0.05% w/v aqueous nasal spray solution)

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