HPS Pharmacies wishes to advise that Johnson & Johnson has discontinued Nicorette® inhalation cartridges, as follows:
Nicorette® Inhalation Cartridge
Nicotine 15mg
ARTG 80874
Alternative presentations of nicotine replacement therapy remain available. This includes nicotine gum, lozenges, patches, and spray.
Retain this notice in a prominent position, including in other related business units for at least 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 Johnson & Johnson on 1800 029 979 or your pharmacist at HPS Pharmacies.
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HPS Pharmacies wish to advise that Juno Pharmaceuticals is experiencing a supply interruption for Amiodarone Juno ampoules as follows:
Amiodarone Juno Ampoules
Amiodarone hydrochloride 150mg/3mL
ARTG 233673
There are currently limited supplies available of Amiodarone Juno ampoules. This supply interruption is anticipated to continue until late June 2025. During this period, supplies of Cordarone® X (amiodarone) 150mg/3mL ampoules may also be impacted.
The Therapeutic Goods Administration (TGA) has not yet authorised the supply of a Section 19A alternative. If required, access to alternative options via the Special Access Scheme (SAS) may be considered. The lead time for accessing SAS stock is longer.
Retain this notice in a prominent position, including in other related business units until supplies return to normal. 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.
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Further to DrugAlert vol 966 and vol 990, HPS Pharmacies wishes to advise that Novo Nordisk is discontinuing the following insulin products:
| Product to be discontinued |
Planned discontinuation date |
Potential alternatives available |
Fiasp® (insulin aspart)
- FlexTouch® prefilled pen
- Vials
|
March 2025 (pen)
December 2024 (vials) |
Fiasp® (insulin aspart) Penfill® cartridge |
| Ryzodeg® (Insulin degludec + insulin aspart 70/30)
|
February 2025 |
Ryzodeg® (Insulin degludec + insulin aspart 70/30) Penfill® cartridge |
| Actrapid® (insulin neutral)
|
December 2026 |
- Humulin® R (insulin neutral) cartridge
- Actrapid® (insulin neutral) vial
|
Protaphane® (insulin isophane)
- InnoLet® prefilled pen
- Penfill® cartridge
|
February 2025 (Innolet®)
December 2026 (Penfill®) |
- Humulin® NPH (insulin isophane) cartridge
- Protaphane® (insulin isophane) vial
|
Levemir® (insulin detemir)
- FlexPen® prefilled pen
- Penfill® cartridge
|
December 2026 |
No other insulin detemir products available.
Alternative long-acting insulin may be considered on a case-by-case basis. |
The Therapeutic Goods Administration (TGA) has implemented a Serious Scarcity Substitution Instrument (SSSI) for Protaphane® InnoLet® and Ryzodeg® FlexTouch®. This allows pharmacists to substitute the presentation form of the unavailable product, providing the conditions of the SSSI are met.
Further information about these supply changes can be found on the TGA website. The Australian Commission on Safety and Quality in Health Care has also produced guidance for clinicians. This details important safety considerations when changing insulin products.
Reminder: insulin is a high-risk medication commonly involved in incidents resulting in serious harm.
Retain this notice in a prominent position, including in other related business units for at least 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 Novo Nordisk on 1800 668 626 or your pharmacist at HPS Pharmacies.
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Further to DrugAlert volume 951, HPS Pharmacies wish to advise that all suppliers are experiencing a supply interruption for gentamicin 80mg/2mL ampoules. This has also led to some supply issues for tobramycin vials.
Gentamicin
Normal supplies of Gentamicin Noridem are expected to resume in early March 2025. Pfizer Gentamicin ampoules are currently unavailable and not expected to return until June 2025.
Two internationally registered alternatives have been approved for supply under Section 19A of the Therapeutic Goods Act 1989. One of these products is registered in Germany and all labelling is in the German language. However, the active ingredient and strength are readily identifiable in English. A comparison of these products is shown in the table below.
| |
Pfizer Gentamicin |
Gentamicin Noridem |
Gentamicin Amdipharm |
Gentamicin Hexal |
| Country of registration |
Australia |
Australia |
UK |
Germany |
| Pack size |
10 or 50 ampoules |
50 ampoules |
10 ampoules |
5, 10, or 20 ampoules |
| Ampoule type |
Plastic |
Glass |
Glass |
Glass |
| Excipients |
- Disodium edetate
- Water for injection
- Sodium hydroxide
- Sulfuric acid
|
- Disodium edetate
- Sodium Metabisulfite
- Water for Injections
- Sodium hydroxide
- Sulfuric acid
|
- Water for injection
- Sodium hydroxide
|
- Disodium edetate
- Water for Injection
- Sodium hydroxide
- Acetylcysteine
|
| Storage |
< 25°C. Protect from light. |
< 25°C |
Do not store above 25°C. Do not freeze. |
This medicinal product does not require special storage conditions. |
| Product information |
Download here |
Download here |
Download here |
Download here |
Please review the excipients of each product carefully, particularly for patients with hypersensitivities or where alternative routes of administration are used. For example, the off-label administration of gentamicin via inhalation requires careful consideration of formulation as excipients may increase the risk of airway irritation.
If an alternative formulation of gentamicin injection is required, the possibility of supply via the Special Access Scheme (SAS) could be explored on a case-by-case basis. The lead time for accessing SAS stock is longer, and ongoing availability is not certain.
The National Centre for Antimicrobial Stewardship publishes fact sheets that provide general recommendations to manage the gentamicin shortage. Individual patient assessment is required when interpreting these recommendations.
Tobramycin
The shortage of gentamicin has led to an increased demand for tobramycin 80mg vials. Tobramycin Viatris 80mg/2mL is currently unavailable and expected to return in late February 2025. Other brands of tobramycin 80mg/2mL vials currently have limited availability in some warehouses.
Retain this notice in a prominent position, including in other related business units until supplies return to normal. 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.
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HPS Pharmacies wish to advise that Juno/Arrotex has updated the packaging for Adrenaline Aguettant 1:10,000 adrenaline (epinephrine) pre-filled syringes as follows:
Adrenaline Aguettant 1:10,000
Adrenaline (epinephrine) (as acid tartrate) 1 mg/10 mL
ARTG 282377
Changes to the packaging have been made to enhance patient safety and reduce the risk of medication errors. Key changes include:
- Highlighting the active ingredient with a black background;
- Placing the active ingredient name on both sides of the syringe and foil so that it is viewable regardless of how the syringe is lying;
- Increasing the green colour on the syringe and blister, aiding differentiation with other pre-filled syringes;
- Changing the outer foil to purple to match the vasopressor colour recommended in the guidelines.
Examples of the new packaging are shown below. No changes have been made to the product itself.
Pre-filled syringe
Outer foil
Outer carton
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 Juno Pharmaceuticals on (03) 8888 1288, or your pharmacist at HPS Pharmacies.
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HPS Pharmacies wish to give notice that Cipla, in consultation with the Therapeutic Goods Administration (TGA), has initiated an urgent product quarantine for Cipla Hydrocortisone 100mg Vials as follows:
Cipla Hydrocortisone Vials
Hydrocortisone (as sodium succinate) 100mg
ARTG 373394
This drug quarantine was initiated due to the discovery of an unknown contaminant.
The only batch affected by this notice is HY0082401A, with an expiry date of 04/2026.
Please inspect your stock and quarantine any stock from the affected batch. 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 and must not be used at this time. Further instructions will be provided once the results of Cipla’s investigation are known. 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 Cipla on (03) 9696 4438 9 or your pharmacist at HPS Pharmacies.
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HPS Pharmacies wish to give notice that Advanz is experiencing a supply issue for Mytolac® as follows:
Mytolac® Pre-filled Syringe
Lanreotide (as acetate) 90mg
ARTG 371880
To address this issue, Advanz is supplying Mytolac® 90mg, originally manufactured for the German market. The product is presented in the outer carton normally used for the Australian market and contains an Australian product information leaflet. However, the syringe and pouch labels are in German.
As the outer carton will appear the same as the usual product supplied in Australia, the batch number can be used to identify products containing the German inner pouch. The only batch affected is 4400167IR1 (Expiry 01/2026). Subsequent batches will return to the full Australian packaging and labelling.
Outer carton (English labelling)
Inner pouch (German labelling)
Please note: The formulation of the German product is identical to the Australian-registered product. They are also manufactured in the same facility to the same specifications and standards.
Where this product is supplied to patients for self-administration, the patient or carer must be informed of this temporary change in labelling.
Retain this notice in a prominent position, including in other related business units until supplies return to normal. Report any problems identified with medicines, vaccines or medical devices to the TGA.
Further information provided by Advanz can be accessed here. Should you require additional information regarding this matter, please contact Advanz on (02) 9431 6333 or your pharmacist at HPS Pharmacies.
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HPS Pharmacies wish to give notice that Baxter, in consultation with the Therapeutic Goods Administration (TGA), has initiated a drug recall for Sodium Chloride bags as follows:
Baxter 0.9% Sodium Chloride Injection BP Bag
Sodium Chloride 2.25g/250mL
ARTG 48517
This drug recall was initiated following the identification of a weak seal on the side of the intravenous solution bag, which may result in leakage when the bag is squeezed. This presents a risk of microbial contamination, delays in therapy, or under-delivery of therapy. Baxter has not received any reports of adverse events associated with this issue.
The batches affected by this recall are:
- X83L8
- X83P7
- X83P8
- X83L9
- X83S9
- X84F1
Please inspect your stock and quarantine any defect stock. If HPS Pharmacies provides this product on imprest 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 Baxter on 1800 229 837 or your pharmacist at HPS Pharmacies.
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HPS Pharmacies wish to give notice that Viatris is experiencing some supply issues for midazolam as follows:
Midazolam Viatris
Midazolam 5 mg/5 mL
ARTG 160206
Supplies of this product are currently limited, although warehouses do still have stock available.
To address the supply issues, the sponsor has made alternative supply arrangements under Section 14 and 14A of the Therapeutic Goods Act 1989. This has allowed Viatris to supply an equivalent product that is registered in New Zealand. This approval is valid until November 2025. However, Viatris anticipates that this replacement stock will only be required between mid-January and mid-March 2025.
The formulation of the NZ registered product is identical to the Australian-registered product. However, the NZ product has additional routes of administration listed on the packaging that are not registered in Australia. The NZ product will be supplied with an over label to include Australian registration details.
The Australian Product Information should be referred to for further information, including administration advice. If patients require further information, they should be directed to the Australian Consumer Medicines Information leaflet.
Retain this notice in a prominent position, including in other related business units until supplies return to normal. Report any problems identified with medicines, vaccines or medical devices to the TGA.
Should you require further information regarding this matter, please contact Viatris on 1800 274 276 or your pharmacist at HPS Pharmacies.
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Further to DrugAlert vol 966, HPS Pharmacies wishes to advise that Novo Nordisk is discontinuing the following insulin product:
Protaphane® InnoLet®, 3mL
Human insulin 100 units/mL
ARTG 169633
Protaphane® InnoLet® is due to be deleted from the market on 1st February 2025.
The Therapeutic Goods Administration (TGA) has implemented a Serious Scarcity Substitution Instrument (SSSI) to help manage this situation. The SSSI allows pharmacists to supply Protaphane® Penfill (100 units/mL) 3mL cartridges, providing the conditions of the SSSI are met, including:
- Patient is provided with a suitable insulin delivery system to administer their medication; and
- Patient or person acting on their behalf is educated on the differences between the presentations and how to correctly administer the substituted medicine.
This SSSI is in force until 28 February 2026, unless revoked earlier by the TGA. Further information can be found on the TGA website. Information on Pharmaceutical Benefits Scheme (PBS) subsidy arrangements for medicines substituted using an SSSI can be found on the PBS website.
Retain this notice in a prominent position, including in other related business units for at least 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 Novo Nordisk on 1800 668 626 or your pharmacist at HPS Pharmacies.
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