PRA number
2017/15927
Published date
Product description
Difflam Sore Throat Ready to Use Iodine Gargle (povidone-iodine 10mg/mL) 200 mL Bottle
Batch Number: 707062
Expiry: May 2018
AUST R: 170543
Batch Number: 707062
Expiry: May 2018
AUST R: 170543
What are the defects?
An out-of-specification (OOS) result has been recorded for povidone-iodine assay in one batch of the Difflam Sore Throat Ready to Use Iodine Gargle (povidone-iodine 10mg/mL) 200mL bottle. The OOS result for povidone-iodine assay occurs early in the product's shelf-life (2 months).
What are the hazards?
This may result in reduced efficacy of the product.
What should consumers do?
Consumers should return the product to the place of purchase for a full refund.
Supplier
iNova Pharmaceuticals (Australia) Pty Limited
Where the product was sold
Nationally
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.