Product Notice
HPS Pharmacies wish to give notice that Aspen Australia has identified a packaging issue for the following products:
| Product | ARTG |
|---|---|
| Marcain® 0.25% with adrenaline 1:400,000 20mL injection vial | 125878 |
| Marcain® 0.5% with adrenaline 1:200,000 20ml injection vial | 48329 |
| Xylocaine® 0.5% with adrenaline 1:200,000 20ml injection vial | 12008 |
| Xylocaine® 1% with adrenaline 1:200,000 20ml injection vial | 12015 |
| Xylocaine® 2% with adrenaline 1:200,000 20mL injection vial | 12021 |
Some batches of the above products may contain a red/brown staining on the lidding paper. Aspen Australia advises that this is purely a cosmetic issue and does not affect the quality of the products.
Glass vials are non-permeable. Therefore, the staining does not pose a sterility assurance risk to the contents of the vial. In regards to the sterility assurance of the blister or theatre packaging, Aspen advises that all released products have met in process inspection and release criteria. Testing includes the vacuum leak test which confirms that staining as a result of ink or potential moisture residue on the lidding paper does not pose a risk of microbial contamination to the inside of the blister pack (theatre pack). Theatre packs should not be used if they are not sealed or the packaging is torn.
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 your pharmacist at HPS Pharmacies, or Aspen Australia on 1300 659 646.
Subscribe Knowledge Centre Updates
Enter your details to receive Knowledge Centre updates