ORSPEC Pharma Pty Ltd — Ruzurgi Amifampridine 10 mg Tablet Bottle

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.

Traders who sold this product

Hospitals and Clinicians in NSW, QLD, VIC, SA and WA.

Where the product was sold

New South Wales
South Australia
Western Australia

Responsible regulator

Therapeutic Goods Administration is the responsible regulator for this recall.

Product category