Defect Correction for Sublimaze® Injection

HPS Pharmacies wish to give notice that Piramal Critical Care, in consultation with the Therapeutic Goods Administration (TGA), has initiated a product defect correction for Sublimaze^® ampoules as follows:

Sublimaze^® Ampoules
Fentanyl (as citrate) 100 microgram/2mL
ARTG 48263

 This notice affects the following batches:

• 2307459 (expiry May 2026)
• 2307460 (expiry June 2026)

This product defect correction was initiated due to some cases of damaged or broken ampoules in unopened blister packs. The issue is readily identifiable prior to use.

Piramal Critical Care advises healthcare professionals to:

• Ensure sufficient stock prior to surgeries;
• Inspect stock and do not open blister packaging on ampoules that appear to be damaged or broken;
• If an ampoule is damaged, closely inspect the remaining ampoules in the blister pack before use; and
• Non-defective ampoules from the affected batches may be safely used as normal.

Please inspect your stock and quarantine all affected products. If HPS Pharmacies provide imprest management services to your facility, an HPS representative will inspect all stock stored in the designated imprest areas at the earliest opportunity. All affected products will be quarantined for return to the supplier, and HPS Pharmacies will arrange for replacement stock as soon as possible. An HPS Pharmacies staff member will contact senior medical and nursing staff if there is an immediate impact to your facility.

Retain this notice in a prominent position, including in other related business units for one month. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact Piramal Critical Care at [email protected], or your pharmacist at HPS Pharmacies.

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