TGA
Consumers and health professionals are advised that Phebra Pty Ltd, in consultation with the TGA, has initiated a product defect alert for bottles of Ospolot (sulthiame) 200 mg tablets.
The affected batch numbers are:
- 18003717 (expiry 05/21)
- 28811 (expiry 11/22)
Ospolot (sulthiame) 200 mg tablets are used as an anticonvulsant for behavioural disorders associated with epilepsy; hyperkinetic behaviour; temporal lobe epilepsy; myoclonic seizures; grand mal attacks and Jacksonian seizures.
It has been identified that affected batches of Ospolot (sulthiame) 200 mg tablets have been supplied with child-resistant caps that 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.
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