HPS Pharmacies wish to give notice that Seqirus Pty, in consultation with the Therapeutic Goods Administration (TGA), has issued a product defect correction for Ryaltris® nasal spray, as follows:
Ryaltris Nasal Spray
Olopatadine 600mcg + Mometasone furoate 25mcg/actuation
ARTG 312690
The following batches are affected by this notice:
| 240 Metered Dose Spray |
56 Metered Dose Spray |
- 12230928 (Expiry 08/2026)
- 12230929 (Expiry 08/2026)
- 12230941 (Expiry 08/2026)
- 12231020 (Expiry 09/2026)
- 12231116 (Expiry 10/2026)
|
- 12231020 (Expiry 09/2026)
- 12230943 (Expiry 0/2026)
|
This defect correction was initiated due to a technical labelling issue. The batch number and expiry date on the affected batches can be smudged or blurred upon contact with an alcohol-based solvent.
Seqirus advises customers to:
- Ensure that alcohol-based sanitisers or wipes do not come into contact with the bottle label; and
- Retain the carton for the duration of use to maintain a durable record of the batch number and expiry details.
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 Seqirus on 1800 008 275 or your pharmacist at HPS Pharmacies.
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HPS Pharmacies wish to give notice that Haleon Australia, in consultation with the Therapeutic Goods Administration (TGA), has issued a product defect correction and recall for Panadol® Children 1 Month – 1 Year, as follows:
Panadol Children 1 Month – 1 Year
Paracetamol 100 mg/mL
ARTG 83363
The following batches are affected by this notice:
- DR562 (Exp 30/04/2024)
- DR563 (Exp 30/04/2024)
- DT528 (Exp 30/04/2024)
- DS947 (Exp 31/07/2024)
- DS956 (Exp 31/08/2024)
- DT334 (Exp 30/09/2024)
- DT469 (Exp 30/09/2024)
- DT762 (Exp 31/10/2024)
- DT912 (Exp 31/10/2024)
- DU128 (Exp 30/11/2024)
- DT913 (Exp 31/10/2024)
- DW301 (Exp 28/02/2025)
- DW507 (Exp 28/02/2025)
- DW487 (Exp 28/02/2025)
This defect correction was initiated as the supplied dosing syringe may be stiff and difficult to use. This may make it difficult to control the delivery of the medicine and may pose a risk of choking. There are no safety or quality problems with the liquid medicine itself.
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 Haleon on 1800 028 533 or your pharmacist at HPS Pharmacies.
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HPS Pharmacies wish to advise that Bristol-Myers Squibb is anticipating a supply interruption for Orencia® as follows:
Orencia® ClickJect®
Abatacept 125mg
ARTG 236039
Orencia® Prefilled Syringe
Abatacept 125mg
ARTG 206764
Manufacturing issues are expected to impact supplies of Orencia® ClickJect® from early June to end-August 2024. Orencia® prefilled syringes are expected to be in short supply from mid-June to end-September 2024 due to increased demand.
Bristol-Myers Squibb is working to control the supply of these products. The Therapeutic Goods Administration (TGA) is also investigating strategies to minimise patient impact, which may include the creation of a Serious Scarcity Substitution Instrument (SSSI). Further information is available on the TGA website.
These supply issues only affect the subcutaneous presentation of Orencia®. Bristol-Myers Squibb advises that there is sufficient stock of Orencia® 250mg vials for intravenous infusion to support patients currently receiving it.
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 Bristol-Myers Squibb on 1800 067 567, or your pharmacist at HPS Pharmacies.
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HPS Pharmacies wishes to advise that Sanofi-Aventis is discontinuing Lasix® 40mg ampoules as follows:
Lasix® Ampoules
Furosemide 40mg/4mL
ARTG 76767
Other strengths of furosemide ampoules are not affected by this notice.
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 Sanofi-Aventis on 1800 818 806 or your pharmacist at HPS Pharmacies.
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HPS Pharmacies wishes to advise that Janssen-Cilag is discontinuing Tracleer® tablets as follows:
Tracleer® Tablets
Bosentan 62.5mg
ARTG 91919
Tracleer® Tablets
Bosentan 125mg
ARTG 91920
The decision to discontinue Tracleer® tablets is a commercial one and not related to any safety, efficacy, or quality issues. Generic alternatives of each strength continue to be marketed in Australia.
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 Janssen-Cilag on 1800 226 334 or your pharmacist at HPS Pharmacies.
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HPS Pharmacies wishes to advise that Novartis Pharmaceuticals have discontinued their diclofenac eye drops and suppository preparations as follows:
Voltaren® Ophtha Eye Drops
Diclofenac sodium 1mg/mL
ARTG 96654
Voltaren® Suppository
Diclofenac 12.5mg
ARTG 96797
Voltaren® Suppository
Diclofenac 25mg
ARTG 96810
Voltaren® suppositories are still available in strengths of 50mg and 100mg.
Alternative non-steroidal anti-inflammatory drugs (NSAIDs) available in eye drop preparations are ketorolac and nepafenac. The product information documents can be consulted for further information on suitability.
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 Novartis Pharmaceuticals on 1800 671 203 or your pharmacist at HPS Pharmacies.
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HPS Pharmacies wish to give notice that Lacuna Pharma, in consultation with the Therapeutic Goods Administration (TGA), has initiated a drug recall for K-Citra 10 tablets as follows:
K-Citra 10 Tablets
Potassium Citrate 1080mg
ARTG 405527
The batches affected by this drug recall are:
- 42301133-B (Exp: 02/2026)
- 42204121-B (Exp: 02/2026)
This drug recall was initiated due to a typographical error on the product label of the two batches mentioned above. The product label contains the incorrect strengths of 629.4 mg for the Potassium component and 390.6 mg for the Citrate.
The correct concentration of Equivalent Potassium is 390.6 mg, and the correct concentration of Equivalent Citrate is 629.4 mg.
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 Lacuna Pharma on (02) 4339 4239 or your pharmacist at HPS Pharmacies.
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Further to DrugAlert vol 915, HPS Pharmacies wish to give notice that Aspen Pharmacare Australia is experiencing a supply interruption for the following local anaesthetic products:
| Product |
ARTG |
Anticipated availability |
| Xylocaine 2% Adrenaline 1:200,000 5X20mL (theatre pack) |
12021 |
Early June 2024 |
| Xylocaine 0.5% Adrenaline 1:200,000 5X20mL (theatre pack) |
12008 |
Long term out of stock |
| Marcain 0.25% with Adrenaline 1:400,000 5x20mL (sterile theatre pack) |
125878 |
Mid-April 2024 |
| Marcain 0.5% with Adrenaline 1:200,000 5x20mL (sterile theatre pack) |
48329 |
Mid-late May 2024 |
All other Aspen local anaesthetic products are available.
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, or Aspen Pharmacare Australia on 1300 659 646.
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HPS Pharmacies wish to advise that Fresenius Kabi is currently experiencing a supply interruption for Fresofol® as follows:
Fresofol® 1% MCT/LCT
Propofol 500mg/50mL
ARTG 193609
Normal supplies of Fresofol® 1% MCT/LCT 50mL vials are expected to resume by late April 2024. The 20mL and 100mL presentations of Fresofol® 1% MCT/LCT are currently unaffected and can be ordered as normal.
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 Fresenius Kabi on (02) 9391 5555, or your pharmacist at HPS Pharmacies.
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Further to DrugAlert volume 917, HPS Pharmacies wishes to advise that some morphine oral solutions available under Section 19A of the Therapeutic Goods Act 1989 are now subsidised on the Pharmaceutical Benefits Scheme (PBS).
Section 19A products now subsidised on the PBS include:
- Morphine sulfate 10mg/5mL oral solution (Martindale Pharma)
- A-flagged to Ordine® 2 in the PBS schedule for general listings; no a-flagging for palliative care listing
- Product contains ethanol (0.4mL/5mL) and sucrose (2.25g/5mL).
- Morphine sulfate 10mg/5ml oral solution (Hikma)
- A-flagged to Ordine® 2 in the PBS schedule for general listings; no a-flagging for palliative care listing
- Sugar and alcohol free
- Morphini HCl Streuli (morphine hydrochloride) 10mg/mL oral drops (Switzerland)
- A-flagged to Ordine® 10 in the PBS schedule for general and palliative care listings
- Product is not labelled in English; additional care required when storing and dispensing this medicine. Health professionals should refer to the Australian product information for dosing information.
- Product contains alcohol (1.2% v/v).
Further information on PBS subsidies for S19A products is available on the PBS website.
Arrotex has taken over the sponsorship of Ordine® products and anticipates that supplies of all strengths of Ordine® Oral Solution will resume by late August 2024.
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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