Phebra has initiated a product defect alert for bottles of Ospolot (sulthiame) 200mg tablets
Phebra Pty Ltd, in conjunction with the TGA, made the announcement on Thursday after it was identified that the child-resistant caps may not function correctly.
“If this occurs, a child may be able to open a bottle and access the medicine, which could result in a potentially life-threatening risk,” the TGA advised.
The affected batch numbers are 18003717 (expiry 05/21); and 28811 (expiry 11/22).
The TGA and Phebra advised that if a child accidently ingests Ospolot (sulthiame) 200 mg tablets, contact the Poisons Information Centre on 13 11 26.
They asked patients taking the medicine, or their carers, to check the batch number and if their medicine is from an affected batch, to exercise extra vigilance and caution when storing it.
Phebra said that it is writing to to all pharmacies and hospital pharmacies who have purchased this product, advising them about this product defect alert.
“Check your stock for any bottles from the affected batches,” it advised.
“If you are treating patients who are taking Ospolot (sulthiame) 200mg tablets, advise them of this issue so that extra vigilance and caution is exercised when storing this medicine.
“As per the product label and information, it is imperative that they keep the medicine out of reach of children.
“If you have any questions or concerns about this issue, contact Phebra Pty Ltd on 02 9420 9199 and ask to speak to the Medical Information Manager.”