Drug Recall for Aciclovir ACCORD 500 mg/ 20mL injection vials

HPS Pharmacies wish to give notice that Accord Healthcare, in consultation with the Therapeutic Goods Administration (TGA), has initiated a drug recall for Aciclovir ACCORD 500 mg/ 20mL injection vials as follows:

Aciclovir ACCORD

Aciclovir 500 mg/ 20mL injection vials

ARTG 313549

The only batch affected by this drug recall are:

  • M2313158 (Exp: 03/2025)

This drug recall was initiated due to Batch No. M2313158 possibly containing a glass particle contaminant within the vial solution. This problem was reported by the manufacturer after inspection of retention samples.

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 Accord Healthcare on 1800 222 673 or your pharmacist at HPS Pharmacies.

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Availability of Morphine Oral Solution

Further to DrugAlert volume 917, HPS Pharmacies wishes to provide an update on the availability of morphine oral solution. While Ordine® Oral Solution was discontinued by Mundipharma in 2023, Arrotex Pharmaceuticals has taken over sponsorship of the Ordine® range and anticipates a return to normal supply later this year.

The table below details the expected return dates for each strength of morphine oral liquid (currently branded as Ordine®, but may be rebranded).

Morphine Oral Liquid Strength Estimated return date Overseas alternative (S19A)
1 mg/mL 27 September 2024 Yes
2 mg/mL 23 August 2024 Yes (also PBS listed)
5 mg/mL 27 September 2024 Yes – available mid-July 2024
10 mg/mL 29 November 2024 Yes – available mid-July 2024 (also PBS listed)

Information to note when considering one of the S19A alternatives includes:

  • Morphine sulfate 10mg/5mL oral solution (Martindale Pharma)
    • Warning – this product contains ethanol (0.4mL per 5mL) and sucrose (2.25g per 5mL).
  • Morphini HCl Streuli (morphine hydrochloride) 10mg/mL oral drops (Switzerland)
    • Warning – this product is not labelled in English. Additional care is required when storing and dispensing this medicine. Appropriate auxiliary labels should be provided. Health professionals should refer to the Australian product information for dosing information.
    • Warning – this product contains alcohol (1.2% v/v).

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 Arrotex on 1800 195 055 or your pharmacist at HPS Pharmacies.

 

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Availability of OxyNorm®

Further to DrugAlert volume 896, HPS Pharmacies wish to advise that Mundipharma has reversed its decision to discontinue OxyNorm® (oxycodone) capsules. While Mundipharma will continue to supply OxyNorm® capsules, OxyNorm® 10mg capsules are experiencing a supply interruption.

OxyNorm® Capsules
Oxycodone 10mg
ARTG 74143

Normal supplies of OxyNorm® 10mg capsules are expected to return by the end of 2024. OxyNorm® 5mg and 20mg capsules are currently 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 Mundipharma on 1800 188 009 or your pharmacist at HPS Pharmacies.

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Availability of Wafermine™ Update

Dear Valued Client,

Further to DrugAlert volume 945, HPS Pharmacies wish to advise that iX Syrinx is continuing to experience a supply interruption for Wafermine™ as follows:

Wafermine™ Wafers
Ketamine 25mg

Wafermine™ Wafers
Ketamine 50mg

Normal supplies of Wafermine™ 25mg and 50mg wafers are now expected to return by 20 July 2024.

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 iX Syrinx on (03) 9737 4333, or your pharmacist at HPS Pharmacies.

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Availability of Wafermine™

HPS Pharmacies wish to advise that iX Syrinx is experiencing a supply interruption for Wafermine™ as follows:

Wafermine™ Wafers
Ketamine 25mg

Wafermine™ Wafers
Ketamine 50mg

Normal supplies of Wafermine™ 25mg and 50mg wafers are expected to return by early July 2024.

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 iX Syrinx on (03) 9737 4333, or your pharmacist at HPS Pharmacies.

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Availability of Clexane® 40mg

HPS Pharmacies wish to advise that Sanofi-Aventis Australia is experiencing a short-term supply interruption for Clexane® as follows:

Clexane® Syringe
Enoxaparin sodium 40 mg/0.4 mL
ARTG 221718

Normal supplies of Clexane® 40mg are expected to return by 24 June 2024. Exarane® 40mg is an alternative product that also contains enoxaparin 40mg/0.4mL in a ready-to-use pre-filled syringe. Exarane® 40mg is currently available in some states, but it is also experiencing a temporary supply interruption in some states.

Unlike Clexane® syringes, Exarane® does not have a safety lock system. If Exarane® is used, additional care is required to avoid needlestick injury. Patients or carers supplied Exarane® for self-injection should be educated on how to use the syringes safely. Patient counselling can be complemented with the provision of the consumer medicines information (CMI) document, which contains administration instructions.

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 Sanofi-Aventis Australia on 1800 818 806, or your pharmacist at HPS Pharmacies.

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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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Availability of Gentamicin Ampoules

To address the anticipated supply interruption of Pfizer Gentamicin ampoules from Nov 2024 to March 2025, HPS will move Gentamicin Injection 80mg/2mL to Gentamicin Noridem (supplied by Interpharma) effective from 17th June 2024.

Gentamicin Noridem
Gentamicin (as sulfate) 80mg/2mL
ARTG 391250

Gentamicin Noridem is an Australian registered product that also contains gentamicin (as sulfate) 80mg/2mL. This is a suitable alternative in most situations. However, this product contains sodium metabisulfite as a preservative. In susceptible people, this sulfite can cause allergic-type reactions, which may be severe.

In comparison, the Pfizer Gentamicin product does not contain any antimicrobial preservative. This should be taken into consideration, particularly for healthcare professionals who may have used Pfizer Gentamicin injection ampoules via an alternative route of administration. In these cases, clinicians may need to consider other therapies. If a sulfite-free gentamicin product 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.

Retain this notice in a prominent position, including in other related business units. 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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Recall for Levomepromazin-Neuraxpharm Ampoules

HPS Pharmacies wish to give notice that Link Medical Products, in consultation with the Therapeutic Goods Administration (TGA), has initiated a drug recall for Levomepromazin-Neuraxpharm Ampoules as follows:

Levomepromazin-Neuraxpharm Ampoules
Levomepromazine 25mg/1mL

The only batch affected by this drug recall is: 220731 (expiry 11/2026).

This drug recall was initiated due to overseas reports of brownish discolouration on individual ampoules, which indicates a quality problem. Please note that this product is not registered on the Australian Register of Therapeutic Goods (ARTG). It would only have been supplied via the Special Access Scheme (SAS).

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 Link Medical on (02) 8401 9788 or your pharmacist at HPS Pharmacies.

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Availability of Cisplatin

HPS Pharmacies wish to advise that Accord Healthcare is experiencing a supply interruption for cisplatin as follows:

Cisplatin Accord
Cisplatin 50 mg/50 mL
ARTG 286786

 Cisplatin Accord
Cisplatin 100 mg/100 mL
ARTG 286791

Normal supplies of the 50mg presentation are expected to resume by end-July 2024; supplies of the 100mg presentation are expected by end-June 2024. Supplies of DBL Cisplatin 100mg/100mL are expected to be available from early June 2024. Limited supplies of DBL Cisplatin 50mg/50mL are currently available in some warehouses.

Two internationally registered brands of cisplatin have been approved for supply via Section 19A of the Therapeutic Goods Act 1989. Both products contain cisplatin 100mg/100mL. The Fresenius Kabi (USA) product is presented as multiple dose vials and the Accord (UK) product is presented as single-use vials.

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 Accord on 1800 222 673, or your pharmacist at HPS Pharmacies.

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