Drug Recall for InterPharma Sodium Chloride 0.9% 30mL

Further to DrugAlert volume 899, HPS Pharmacies wish to give notice that InterPharma, in consultation with the Therapeutic Goods Administration (TGA), has initiated an urgent recall of all batches of Sodium Chloride 0.9% 30mL irrigation Solution.

This recall has been initiated due to possible contamination with Ralstonia pickettii, a bacteria that can cause infection in people with a weakened immune system.

The products currently affected by this issue are shown below.

InterPharma Sodium Chloride 0.9% 30mL ampoules: (Recall)

  • ALL batches

InterPharma Sodium Chloride 0.9% 10mL ampoules: (Quarantine)

  • 2304400
  • 2301530
  • 2301531
  • 2207874

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, 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 InterPharma on 1300 308 213 or your pharmacist at HPS Pharmacies.

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Drug Quarantine Update for InterPharma Sodium Chloride 0.9%

Further to DrugAlert volume 898, HPS Pharmacies wish to give notice that InterPharma has extended the quarantine to include all batches of Sodium Chloride 0.9% 30mL irrigation Solution. The batches currently affected by this quarantine are shown below.

InterPharma Sodium Chloride 0.9% 10mL ampoules:

  • 2304400
  • 2301530
  • 2301531
  • 2207874

InterPharma Sodium Chloride 0.9% 30mL ampoules:

  • ALL batches

InterPharma advise that alternative options for the 30mL irrigation solution include unaffected batches of Sodium Chloride 0.9% for Injection ampoules (10mL or 20mL) or Sodium Chloride 0.9% Irrigation sachets (30mL).

This urgent product quarantine has been initiated owing to possible contamination with Ralstonia pickettii. Whilst this has not yet been confirmed, as a precaution, products from the affected batches should be removed from use immediately and quarantined until further notice.

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, 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 InterPharma on 1300 308 213 or your pharmacist at HPS Pharmacies.

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Drug Quarantine for InterPharma Sodium Chloride 0.9%

HPS Pharmacies wish to give notice that InterPharma, in consultation with the Therapeutic Goods Administration (TGA), has initiated a drug quarantine for the 10mL and 30mL presentations of InterPharma Sodium Chloride 0.9% ampoules:

The following batches of 10mL ampoules are affected:

  • 2304400
  • 2301530
  • 2301531
  • 2207874

The following batches of 30mL ampoules are affected:

  • 2386043E
  • 2386048E
  • 2386051E
  • 2286030E

This urgent product quarantine has been initiated owing to possible contamination with Ralstonia pickettii. This is due to reported cases of R. pickettii in multiple jurisdictions. Whilst this has not yet been confirmed, as a precaution, products from the affected batches should be removed from use immediately and quarantined until further notice.

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, 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 InterPharma on 1300 308 213 or your pharmacist at HPS Pharmacies.

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Drug Recall for Lisinopril Sandoz

HPS Pharmacies wish to give notice that Sandoz, in consultation with the Therapeutic Goods Administration (TGA), has initiated a drug recall for Lisinopril Sandoz 20mg tablets as follows:

Lisinopril Sandoz
Lisinopril 20ng
ARTG 158108

 The only batch affected by this drug recall is: KF6307 (Exp: August 2024)

This drug recall was initiated following the detection of N-nitroso-lisinopril (NLP) in above acceptable limits.

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 Sandoz on 1800 726 369 or your pharmacist at HPS Pharmacies.

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Discontinuation of OxyNorm®, MS Mono® and Sevredol®

HPS Pharmacies wish to advise that Mundipharma is discontinuing the following opioid products:

  • OxyNorm® (oxycodone) capsules;
  • MS Mono® (morphine sulfate) modified-release capsules; and
  • Sevredol® (morphine sulfate) tablets

Mundipharma has provided the following estimated dates of discontinuation from the market based on current demand.

Product ARTG Estimated discontinuation date
OxyNorm® 5mg 74145 March 2025
OxyNorm® 10mg 74143 June 2024
OxyNorm® 20mg 74141 March 2025
MS Mono® 30mg 74156 September 2024
MS Mono® 60mg 74154 October 2024
MS Mono® 90mg 74152 August 2024
MS Mono® 120mg 74150 September 2024
Sevredol® 10mg 47543 July 2024
Sevredol® 20mg 214089 April 2024

These dates are estimates only and may be updated on the Medicine shortage reports database if there are any changes in demand.

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 Mundipharma on 1800 188 009 or your pharmacist at HPS Pharmacies.

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Drug Recall for Dasatinib Dr.Reddy’s

HPS Pharmacies wish to give notice that Dr Reddy’s Laboratories, in consultation with the Therapeutic Goods Administration (TGA), has initiated a drug recall for Dasatinib Dr.Reddy’s tablets as follows:

Dasatinib Dr.Reddy’s Tablets
Dasatinib 70mg
ARTG 337456

The only batch affected by this drug recall is: ZH20022 (Exp: Dec 2023)

This drug recall was initiated following out of specification results for dissolution observed during stability testing. Failure in the dissolution test can result in incomplete release of the medicine and lack of efficacy.

There have been no reports of adverse events related to this issue.

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 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 Dr Reddy’s Laboratories on 1800 274 276 or your pharmacist at HPS Pharmacies.

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Packaging Update for Baxter Compounded IV Bags

HPS Pharmacies wishes to give notice that Baxter is updating their IV bags used for compounded chemotherapy, antibiotic, and clinical trial products.

The current Viaflex bags are set to be discontinued and will be replaced with the new Baxter Multilayer EVA bags. The transition period will commence from 4 November 2023.

An example of the current Viaflex bag and the new Multilayer EVA bags are shown below.

Image 1. Comparison of Viaflex and Multilayer EVA bags (image reproduced from Baxter)

Baxter Multilayer EVA bags are available in 125 mL, 250 mL and 1L sizes. Products will transition to the appropriate size bag according to their final volume. There will be no change to labelled stability for these products.

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 (02) 9848 1111 or your pharmacist at HPS Pharmacies.

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Packaging Update for Potassium Chloride 22.3% Concentrated Injection

HPS Pharmacies wish to give notice that Phebra has updated the packaging of Potassium Chloride 22.3% Concentrated Injection as follows:

Potassium Chloride 22.3% Concentrated Injection
Potassium Chloride 2.23 g/10 mL
ARTG 23073

 This product is now supplied with a green seal/cap. There has been no change to the formulation of this product.

Concentrated injections of potassium chloride are high risk medications. 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 Phebra on 1800 720 020 or your pharmacist at HPS Pharmacies.

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Recall of Sodium Chloride 0.9% Freeflex 100mL injection bag

HPS Pharmacies wish to give notice that Fresenius Kabi, in consultation with the Therapeutic Goods Administration (TGA), has initiated a drug recall for Sodium Chloride 0.9% Freeflex bags as follows:

Sodium Chloride 0.9% Freeflex 100mL Injection Bag
Sodium chloride 900 mg/100 mL
ARTG 144609

The manufacturer is recalling one batch after identifying an issue where some Freeflex bags with the white injection port start leaking on withdrawal of the needle after injection.

The only affected batch is 82SG795105

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 Fresenius Kabi on 1300 732 001 or your pharmacist at HPS Pharmacies.

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Defect Correction for Midazolam Alphapharm

HPS Pharmacies wish to give notice that Viatris, in consultation with the Therapeutic Goods Administration (TGA), has initiated a product defect correction for Midazolam Alphapharm injection (now branded as Midazolam Viatris injection) as follows:

Midazolam Alphapharm
Midazolam 50 mg/10 mL
ARTG 160208

The only batch affected by this product defect correction is: F3138F02 (Exp 12/24)

This product defect correction is being undertaken due to the detection of a single ampoule of Urapidil Stragen 50mg/10ml in this batch of midazolam ampoules.

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 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.

Only cartons of Midazolam Alphapharm 50 mg/10 mL Injection that contain an ampoule of Urapidil Stragen are impacted by this event. If no Urapidil ampoules are contained, use of Midazolam Alphapharm from batch F3138F02 may continue.

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 Viatris on 1800 274 276 or your pharmacist at HPS Pharmacies.

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