Chlorhexidine digluconate impregnated cloth
The marketing authorization holder informed its supplied customers in a letter dated 13.09.2016 that its batch of "Chlorhexidine digluconate Sage 20 mg/ml impregnated wipe" must be recalled as it is possibly microbiologically contaminated withbecause it may be microbiologically contaminated with "Burkholderia cepacia". Infected wipes show a light brownish discoloration and have a strong odor. Apparently uninfected wipes may also be infected, therefore the batch must not be further used.
Name of the medicinal product | Chlorhexidindigluconat Sage 20 mg/ml imprägniertes Tuch |
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Marketing authorisation number(s) | 1-31762 |
Marketing authorisation holder | Sage Products Coöperatief U.A. |
Batch number(s) | 50733 |
Classification of the recall | 2 |
BASG reference number | INS - 640.001 - 1820 |