HPS Pharmacies wish to advise that Alphapharm is experiencing a supply interruption for Paxam® 2mg tablets as follows:
Paxam® Tablets
Clonazepam 2mg
ARTG 54847
Normal supplies are expected to return by the end of January 2025.
An internationally registered alternative has been approved for supply under Section 19A of the Therapeutic Goods Act 1989. This product is identical in active ingredient and strength, and all labelling is in English. It is available in bottles of 100 or 500 tablets.
Clonazepam 0.5mg tablets are also experiencing a supply interruption, although this is expected to resolve in the next week. Supplies of clonazepam drops and ampoules are currently unaffected.
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 Alphapharm on 1800 274 276 or your pharmacist at HPS Pharmacies.
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HPS Pharmacies wish to give notice that Dr Falk Pharma Australia, in consultation with the Therapeutic Goods Administration (TGA), has initiated a drug recall for Salofalk® Enema as follows:
Salofalk® Enema
Mesalazine 4 g/60 mL
ARTG 80652
The batches affected by this recall are:
- 230442A (Expiry: July 2025)
- 230443A (Expiry: July 2025)
- 230444A (Expiry: July 2025)
- 230445A (Expiry: July 2025)
This drug recall was initiated as bottles from the affected batches may contain a defect where the one-way valve in the applicator nozzle sometimes becomes stuck, preventing the administration of the enema liquid medicine.
Please inspect your stock and quarantine any defect stock. 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 HPS Pharmacies will arrange for a credit 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 Dr Falk Pharma Australia on 1800 373 255 or your pharmacist at HPS Pharmacies.
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Further to DrugAlert vol 975, HPS Pharmacies wish to give notice that Link Medical Products, in consultation with the Therapeutic Goods Administration (TGA), has issued a product defect alert for their adrenaline pre-filled syringes, as follows:
Adrenaline-Link Pre-Filled Syringe
Adrenaline (epinephrine) acid tartrate 1:10 000 (1mg/10mL)
ARTG 210672
This product defect alert was initiated following reports of blocked syringe bores which made it difficult or impossible to administer this product in an emergency. The use of incompatible connectors and connectors without the appropriate adaptors is the primary cause of blocked syringes.
There have been deaths reported in association with this issue.
Due to the seriousness of this issue, HPS Pharmacies has decided to quarantine all batches of Adrenaline-Link Pre-Filled Syringes.
Adrenaline availability
- Adrenaline Aguettant 1:10,000 pre-filled syringes are currently out of stock and expected to return in mid-late November 2024.
- Adrenaline Aspen 1:10,000 ampoules remain available and are recommended to be used while Adrenaline Aguettant is unavailable.
When using Adrenaline Aspen 1:10,000, users should be mindful of risk of injury due to the presentation in a glass ampoule and the requirements for drawing up doses in a timely manner for emergency situations. If utilising smaller quantities for resuscitation trays or emergency trolleys, clinicians should consider the need to protect individual ampoules from light.
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.
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Further to DrugAlert vol 973, HPS Pharmacies wish to advise that Pfizer is experiencing a supply interruption for heparin as follows:
DBL Heparin Sodium
Heparin sodium 5000IU/1mL
ARTG 12881
This supply interruption is expected to continue until April 2025. Some wholesalers may still have stock, but supplies have been constrained.
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 Pfizer on 1800 675 229 or your pharmacist at HPS Pharmacies.
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Further to DrugAlert vol 953, HPS Pharmacies wish to give notice that Link Medical Products, in consultation with the Therapeutic Goods Administration (TGA), has issued a notice for their adrenaline pre-filled syringes, as follows:
Adrenaline-Link Pre-Filled Syringe
Adrenaline (epinephrine) acid tartrate 1:10 000 (1mg/10mL)
ARTG 210672
This action was initiated following reports of blocked syringe bores which made it difficult or impossible to administer this product in an emergency. The use of incompatible connectors and connectors without the appropriate adaptors are the primary cause of blocked syringes.
The packaging of Adrenaline-Link Pre-Filled Syringes has been updated to include a warning that compatible connectors are required. The following connectors have recently been added to the list of connectors that are compatible with Adrenaline-Link PFS:
- D1000 Tego Connector
- Neutron (when used with 011-CS25 Adaptor).
Availability
Pre-filled syringes (currently out of stock)
- Adrenaline Aguettant 1:10,000 is expected to return in mid-late November 2024.
- Adrenaline-Link 1:10,000 is expected to return in late January 2025.
Ampoules:
- Adrenaline Aspen 1:10,000 ampoules remain available.
Recommendations
Where pre-filled syringes are used, users must ensure any connectors and adaptors used are compatible.
Where adrenaline ampoules are used, users need to be aware of the risk of injury due to their presentation in a glass ampoule and the requirements for drawing up doses in a timely manner for emergency situations. If utilising smaller quantities for resuscitation trays or emergency trolleys, clinicians should consider the need to protect individual ampoules from light.
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.
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HPS Pharmacies wish to give notice that Juno has updated the labelling of their hydromorphone ampoules as follows:
Important: Hydromorphone is a high-risk medication. Always read the label carefully rather than relying on packaging or label recognition when selecting this product.
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 on 1800 276 839 or your pharmacist at HPS Pharmacies.
HPS Pharmacies wish to advise that Pfizer is experiencing a supply interruption for heparin as follows:
Heparin Sodium
Heparin sodium 25,000IU/5mL
ARTG 49236
This supply interruption is expected to be resolved by the end of December 2024.
An internationally registered alternative has been approved for supply under Section 19A of the Therapeutic Goods Act 1989. The alternative product is also preservative-free, and all packaging is in English.
Heparin is a high-risk medication. Additional care is recommended when selecting products, particularly when the packaging may be unfamiliar. The following table compares the Australian-registered product with the S19A alternative.
| |
Heparin sodium 25000IU/5mL (Pfizer) |
Heparin sodium (Wockhardt) preservative-free |
| Product type |
Australian registered |
S19A |
| Excipients |
Water for injection |
- Water for injections
- Sodium hydroxide solution 3M
- Hydrochloric acid 3M
|
| Pack size |
50 Steriluer ampoules |
10 neutral glass ampoules |
| Storage |
< 25°C |
Do not store > 25°C
Store in original package |
| Additional information |
Single-use only |
Single-use only |
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 Pfizer on 1800 675 229 or your pharmacist at HPS Pharmacies.
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HPS Pharmacies wish to advise that all sponsors are currently experiencing a supply interruption for ezetimibe 10mg tablets.
Normal supplies are expected to return in mid-October 2024 for some brands, although other brands are not expected to return until mid-November 2024.
An internationally registered alternative has been approved for supply under Section 19A of the Therapeutic Goods Act 1989. This product is registered for use in the United States and all packaging is in English.
Some ezetimibe combination products may also be affected by supply issues during this period.
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 give notice that Baxter, in consultation with the Therapeutic Goods Administration (TGA), has initiated a product defect correction for Compounded Parenteral Nutrition and IV Solutions.
For a full list of affected products, please click here.
This product defect correction has been initiated following increased reports of particulate matter in disposable inlets used with the ExactaMix (EM2400) Automated Compounding device used by Baxter Compounding for preparation of selected Parenteral Nutrition and IV Solutions. There is a risk that particulate matter may be present in final compounded solutions. There is no risk in relation to sterility of the tubing.
Baxter is working to replace the inlets affected by this issue. Until replacement stock is available, Baxter Compounding has ensured additional measures are in place to minimise the risk of particulates in compounded solutions, including:
- Inspecting the inlets prior to use in compounding;
- Priming the inlets prior to use; and
- Performing Visual Inspection on each filled compounded unit
Baxter also advises healthcare professionals to:
- Inspect and discard/return any product with visible particles; and
- Use an appropriate in-line filter set during the administration of any compounded solutions manufactured using the affected inlets. An in-line filter of not less than 1.2 micron should be used for administration of parenteral nutrition containing a lipid, a 0.22 micron filter can be used for aqueous solutions without a lipid (in line with international guidelines).
Please inspect your stock and quarantine any defect stock. 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 HPS Pharmacies will arrange for a credit 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 advise that Orion is experiencing a supply interruption for Bisalax® as follows:
Bisalax® Enema
Bisacodyl 10mg/5mL
ARTG 27900
This supply interruption is expected to resolve by early November 2024.
An internationally registered alternative has been approved for supply under Section 19A of the Therapeutic Goods Act 1989. This product, Toilax®, is registered for use in Finland and all packaging is in Finnish and Swedish. However, the active ingredient and strength are recognisable in English.
The Finnish product is manufactured in the same facility as the Australian registered product and is identical for active ingredient and strength. The differences between the two products are shown in the table below.
| |
Bisalax® |
Toilax® |
| Product type |
Australian registered |
S19A |
| Labelled strength |
10mg/5mL |
2mg/mL |
| Pack size |
25 enema tubes |
50 enema tubes |
| Language |
English |
Finnish and Swedish |
As the patient leaflet contained within the S19A alternative is not in English, patients can be referred to the Australian Consumer Medicines Information (CMI) brochure.
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 Orion on (02) 8067 8704 or your pharmacist at HPS Pharmacies.
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