Ruzurgi Amifampridine 10 mg Tablet Bottle
Reason for Recall / Hazard
The affected product batch 18039 exceeds the specification for total yeast and mould counts (TYMC).
Product Description & Identification
Reason / Defects: The affected product batch 18039 exceeds the specification for total yeast and mould counts (TYMC). Hazards: 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 to 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.
Affected Products
Ruzurgi amifampridine 10 mg tablet bottle Batch Number: 18039 Exp: 3/2023 Supplied via Special Access Scheme (SAS)
Additional Source Details
| Field | Value |
|---|---|
| Guid › #text | 8b2e0847-f8a3-41fb-a887-5d9ae96b1f67 |
| Guid › @ is Perma Link | false |
| Link | https://www.productsafety.gov.au/search-consumer-product-recalls/ruzurgi-amifampridine-10-mg-tablet-bottle |
| Pub Date | Mon, 04 Oct 2021 00:00:00 +0000 |