PRA number
Published date
Product description
Ruzurgi amifampridine 10 mg tablet bottle
Batch Number: 18039
Exp: 3/2023
Supplied via Special Access Scheme (SAS)
Reasons the product is recalled
The affected product batch 18039 exceeds the specification for total yeast and mould counts (TYMC).
The hazards to consumers
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.
What consumers should do
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.
Supplier
Traders who sold this product
Hospitals and Clinicians in NSW, QLD, VIC, SA and WA.
Where the product was sold
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.