OECDReference EN/AU/PS1095684
Ruzurgi Amifampridine 10 mg Tablet Bottle
Official information organised for easier consultation. The source publication remains authoritative.
Identification
Product identification
- Product
- Ruzurgi Amifampridine 10 mg Tablet Bottle
Official information
Risk and measures
- Risk or hazard
- The affected product batch 18039 exceeds the specification for total yeast and mould counts (TYMC). The effects of increased exposure to yeast and/or mould can include allergic reactions, asthma, neurotoxicity, sinusitis, otomycosis, onychomycosis, keratitis, respiratory infections, skin infections, and systemic infections. This may pose a serious health risk to users with weakened immune systems.
- Recommendations
- Consumers who have been prescribed Ruzurgi Amifampridine 10 mg tablets, should check the batch number printed on the bottle. This recall does not affect any other batch of Ruzurgi, or any other ORSPEC Pharma products. Consumers will be contacted by a clinician to arrange for a replacement product. Anyone who is concerned about the use of this batch of product should consult their doctor. For more information, consumers can contact ORSPEC Pharma Customer Service on 02 4339 4239.
Official information
Economic operators
- Manufacturer
- ORSPEC Pharma Pty Ltd
Territory
Geography
- Distribution
- Retirada en Australia
- Country of recall
- Australia
Provenance and context
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