JANSSEN, in consultation with the Therapeutic Goods Administration, has announced a "product defect correction" for one batch of its Jurnista (hydromorphone hydrochloride) prolonged-release blister packs due to potential tablet damage.
A misalignment issue with a packaging machine resulted in damage to the outer coating on some tablets in batch number IALS400 with a 12-2019 expiry date.
The TGA said the physical damage to the affected tablets is obvious, and could result in faster than intended absorption or active ingredient degradation - tga.gov.au.
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