Bactroban
Recall
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Medicines
|
24/08/2015
The marketing authorization holder has informed its supplied customers in a letter dated 21.08.2015 that the batches listed above were manufactured with an active ingredient batch that may be contaminated with particles of the manufacturing equipment. As there could be irritation of the nasal mucosa/skin due to these particles in the nasal ointment/cream and the amount and size of the potential particles cannot be estimated, a precautionary recall is being carried out.This recall results in a limited availability of Bactroban nasal ointment and cream.
| Name of the medicinal product | 1. Bactroban –Nasensalbe 2. Bactroban 2 % - Creme |
|---|---|
| Marketing authorisation number(s) | 1. 1-20226 2. 1-23206 |
| Marketing authorisation holder | GlaxoSmithKline Pharma GmbH |
| Batch number(s) | 1. C684929, C697794, C700707 2. C697124 |
| Classification of the recall | 2 |
| BASG reference number | INS-640.001-1493 |
Further inquiry note
Page last modified:
12/07/2022