Medication Safety Updates

Medication Safety Communications


Date last updated: 29 Jul 2021

The information provided on this page is intended for use by NSW health clinicians. It may not be relevant to clinicians from other states or territories and is not the complete list of medicine shortages reported to the Therapeutic Goods Administration – refer to the TGA Medication Shortages Information Initiative and Medicines Safety Update.

Medicine Affected Issued Updated Update Status
Azathioprine injection 29-Jul-21 29-Jul-21 The Australian registered product, azathioprine 50 mg powder for injection (Imuran®) will be discontinued and deleted from market on 28 February 2022. Supply of an alternative product Imuran® (Canada) 50 mg injection is available via Advanz Pharma under the Special Access Scheme (SAS) of the Therapeutic Goods Act. Current
Nitrofurantoin 29-Jul-21 29-Jul-21 The Macrodantin® brand of nitrofurantoin 50 mg and 100 mg capsules has/will be discontinued on 1 July 2021 and 4 November 2021 respectively. Consequently there is a shortage of APO-Nitrofurantoin 50 mg and 100 mg capsules due to an increase in demand until 15 October 2021 and 3 September 2021 respectively. Supply of alternative products; nitrofurantoin 50 mg capsules (Sun Pharma, USA) and nitrofurantoin 100 mg capsules (Morningside Healthcare, UK) are available via Medsurge under Section 19A (S19A) of the Therapeutic Goods Act. The S19A 100 mg capsules must be protected from light (not a requirement of the registered product). Current
Etacrynic acid 29-Jul-21 29-Jul-21 The Australian registered product, etacrynic acid 25 mg tablets (Edecrin®) will be discontinued and deleted from market on 15 August 2021. Supply of an alternative product Edecrin® (Canada) 25 mg tablets are available via Medsurge under the Special Access Scheme (SAS) of the Therapeutic Goods Act. Current
Flucytosine 7-Oct-20 29-Jul-21 The Australian registered product, flucytosine (Ancotil®) 2.5 g/250 mL injection will be discontinued and deleted from market on 31 October 2021. iNova Pharmaceuticals have access to a limited supply of flucytosine injection for hospitals who have patients in immediate need of the product. It is anticipated that stock depletion is likely to occur between July and September 2021 (timing is dependent on product demand). After depletion, no further stock will be available. The final batch has an expiry date of 31 October 2021. Supply of an alternative product Ancotil® 1% 2.5 g/250 mL injection (Austria) is available via Medsurge under the Special Access Scheme (SAS) of the Therapeutic Goods Act. Current
Promethazine 29-Jul-21 29-Jul-21 DBL promethazine hydrochloride 50 mg/2 mL injection is out of stock until 30 August 2021. Link and Medsurge have alternative promethazine injection products available via the Therapeutic Goods Administration’s Special Access Scheme. Both companies have also applied to supply under Section 19A (S19A) of the Therapeutic Goods Act 1989 – currently awaiting outcome of application. Details will be updated when available. Current
Atracurium 17-Nov-20 26-Jul-21 Tracrium and DBL brands available for ordering via regular wholesalers. Resolved
Lignocaine (lidocaine) oral gel 7-May-21 26-Jul-21 Disruption to the supply of Mucosoothe oral gel 2% lignocaine 200 mL bottles has been resolved. Stock available through regular wholesalers. Resolved
Tocilizumab 9-Jul-21 19-Jul-21 There are currently supply constraints in place for all strengths and formulations. If supply is required for TGA and S100-approved indications, facilities should continue ordering through their routine purchasing channels and stock will be released based on historical usage. If supply is required for COVID-19 patients, please see the attached information sheet (by clicking on the drug name to the left) for information on how to order this from HealthShare NSW. Current
Labetalol 19-Jul-21 19-Jul-21 The drug sponsor for Trandate tablets has advised that both strengths (100 mg and 200 mg) will be discontinued effective immediately. Presolol brand remains available through regular wholesalers. Clinicians should be aware that Presolol tablets contain sulfites (not present in Trandate). Current
Quinine dihydrochloride 6% solution for injection 6-Jul-21 6-Jul-21 The drug sponsor has advised that this medication will now be supplied in packs of 5 (previously 10). Please see attached letter for further information including new ordering code. Facilities that stock this medication for emergency use may need to increase the number of packs held on-hand. Current
Testosterone undecanoate 40 mg capsule 29-Jun-21 29-Jun-21 The Australian registered product, Andriol Testocaps (testosterone undecanoate 40 mg capsule) has been discontinued. Link Pharmaceuticals may have alternative products available via the Therapeutic Goods Administration’s Special Access Scheme. Local assessments of suitability should be undertaken by the Drug and Therapeutics Committee with particular attention to product labelling. Current
Enoxaparin 29-Apr-21 29-Jun-21 Disruption to the supply of enoxaparin 20 mg and 40 mg strengths of enoxaparin has been resolved. Supply restrictions will remain in place to ensure equitable access – facilities should continue placing orders through regular wholesalers based on historical usage. Resolved
Ketorolac 10 mg/1 mL injection 18-May-21 29-Jun-21 Disruption to supply of Baxter (Claris) brand has been resolved – orders should be placed through regular wholesalers. Facilities that switched to using the 30 mg/1 mL ampoules during the supply disruption should continue to consider potential safety implications discussed in the attached Medication Safety Communication. Resolved
Salbutamol metered dose inhaler 29-Apr-21 24-Jun-21 There has been a recent change in the presentation of salbutamol metered dose inhalers which impacts its off-label use via the endotracheal tube for bronchospasm during anaesthesia. The cannister now has a counter attached, making the adaptor previously used incompatible. Click on the medication name to access the CEC memo regarding this issue recently sent out to CEs and DCGs. A Safety Alert has also been released by ANZCA – https://www.anzca.edu.au/news/safety-alerts-news/safety-alert-ventolin-metered-dose-inhalers Current
Atenolol 50 mg/10 mL oral solution 8-Jun-21 8-Jun-21 Disruption to the supply of Atenolol-AFT 50 mg/10 mL oral solution due to manufacturing delays. Supply of an alternative product, Atenolol 25 mg/5 mL Sugar Free Oral Solution (Essential Generics) is available via LINK under Section 19A (S19A) of the Therapeutic Goods Act 1989. Current
Aciclovir 250 mg/10 mL injection 8-Jun-21 8-Jun-21 Disruption to the supply of DBL aciclovir 250 mg/10 mL injection vials due to a quality assurance batch failure. Normal supply is expected to return in the first week of August. The 500 mg/20 mL strength is currently unaffected and can be ordered from Pfizer or regular wholesalers. Current
OntoTICE BCG (Bacillus Calmette-Guerin) injection vial (antineoplastic) 11-Feb-21 4-Jun-21 The Australian registered product, OncoTICE BCG 5 hundred million CFU powder for injection vial is out of stock until 31 December 2021. Supply of an alternative product, BCG Culture SSI BCG 30 mg/vial (AJ Vaccines), is available via LINK under Section 19A (S19A) of the Therapeutic Goods Act 1989. The S19A product differs from the Australian registered product as they are derived from different substrains of Mycobacterium bovis BCG. Therefore, the recommended therapeutic dose and potency are NOT equivalent. Current
BCG (Bacillus Calmette-Guerin) vaccine powder for injection 4-Jun-21 4-Jun-21 The Australian registered product, BCG Vaccine powder for injection with diluent has been discontinued. Supply of an alternative product, BCG Vaccine SSI – Mycobacterium bovis BCG, Danish strain 1331 (AJ Vaccines), is available via LINK under Section 19A (S19A) of the Therapeutic Goods Act 1989. The S19A product differs from the discontinued Australian product as they derived from different substrains of Mycobacterium bovis BCG. Therefore, the recommended therapeutic dose and potency are not equivalent. There are also differences in the contraindications to use and preparation for the S19A (contact LINK for detailed letter to Healthcare Professionals containing this information). Current
Cernevit injection 1-Jun-21 1-Jun-21 Disruption to the supply of Cernevit injection vials until 30 September 2021. Supply of compounded products available from Baxter containing Cernevit (including TPN) remain unaffected at this time. Alternate parenteral multivitamin preparations (e.g. combination of Soluvit N and Vitalipid N) may be required during this time. Consider differences in presentation, reconstitution steps and formulation – treating clinicians should assess suitability of available alternatives for patients on a case-by-case basis. Resources such as the Australian Society for parenteral and enteral nutrition (AuSPEN) adult vitamin guidelines for parenteral nutrition may aid clinicians in decision-making. Current
Trimethoprim-sulfamethoxazole 80 mg/400 mg injection 6-May-20 1-Jun-21 The expected return to supply date for trimethoprim-sulfamethoxazole 80 mg/400 mg injection has been revised to 8 October 2021. Supply of an alternative product is available via Link under Section 19A (S19A) of the Therapeutic Goods Act. Current
Adrenaline 1:1,000 21-May-20 29-Apr-21 Disruption to the supply of LINK adrenaline 1:1,000 1 mg/1 mL ampoules (both pack sizes) until September 2021. Other brands unaffected at this stage. Current
Glyceryl trinitrate injection 8-Dec-20 29-Apr-21 Supply disruption has been resolved. Stock is being distributed to regular wholesalers and should be available for ordering this week. Resolved
Ergometrine maleate 12-Jan-21 27-Apr-21 Supply disruption has been resolved. Stock is being distributed to regular wholesalers and should be available for ordering this week. Resolved
Furosemide (frusemide) 20 mg/2 mL injection 14-Jan-21 14-Apr-21 Disruption to the supply of Lasix® 20 mg/2 mL injection ampoules until late March 2021. Access to NSW HealthShare stock is open for this strength – follow order process as distributed by HealthShare. If urgent requirement or problems submitting request, contact Noman.Masood@health.nsw.gov.au. Shortage resolved. Resolved
HYDROmorphone (Dilaudid®) Oral Liquid 1 mg/mL 14-Apr-21 14-Apr-21 The Australian registered medicine HYDROmorphone (Dilaudid®) oral liquid 1 mg/mL has been discontinued. Supply of an alternative product, HYDROmorphone Hydrochloride Oral Solution 1mg /mL, USP 473mL (Rhodes), is available via Medsurge under Section 19A (S19A) of the Therapeutic Goods Act until 9 January 2022. Due to this product requiring import and export permits, it will take approximately 3-4 weeks to receive the first shipment. The S19A product differs from Dilaudid® oral liquid in that it contains sodium metabisulfite, a sulfite that may cause allergic type reactions. Use of this product is contraindicated in patients with hypersensitivity to sulfite containing medications. Current
Furosemide (frusemide) 500 mg tablet 3-Mar-21 14-Apr-21 The Australian registered medicine, UREX FORTE furosemide (frusemide) 500 mg tablet is unavailable. Supply of an alternative product, Furosemid-ratiopharm 500 mg, is available via Medsurge under Section 19A (S19A) of the Therapeutic Goods Act. The S19A product differs from Urex Forte® tablets in terms of administration, Furosemid-ratiopharm must be taken on an empty stomach and unchewed with sufficient liquid (e.g. 1 glass of water). Current
Flebogamma 10% DIF – all vial sizes 1-Apr-21 1-Apr-21 All vial sizes of Flebogamma 10% DIF immunoglobulin are temporarily unavailable and cannot be ordered in BloodNET. Click on the medicine name for more information regarding the reallocation process and information for clinic staff. Current
Tenofovir/Emtricitabine 12-Jan-21 24-Mar-21 Recall on all batches of Tenofovir Disoproxil Emtricitabine Mylan 300/200 tablets on 23 December 2020 due to potential for split tablets to lead to ineffective dose. Supply of the Apotex brand should be available at wholesalers. S19A alternative also available through Link Pharmaceuticals until 28 February 2021 – Teva brand imported from the UK. Please note, the S19A product displays the dose of emtricitabine first (200 mg) followed by the dose of tenofovir disoproxil (245 mg). Tenofovir disoproxil is the active ingredient name – all brands ultimately have 245 mg of tenofovir disoproxil but are presented in different salt forms. Shortage resolved. Resolved
Ceftolozane/tazobactam 12-Jan-21 24-Mar-21 The recall on all batches of ceftolozane/ tazobactam (Zerbaxa®) in December 2020 (due to sterility results of numerous batches being out of specification) continues to impact the supply of Zerbaxa® worldwide. The published expected supply date for Zerbaxa® has been revised to 1st January 2022. Alternative therapy should be sought in consultation with local Infectious Diseases/Microbiology service. Current
Prednisolone acetate 1%/phenylephrine 0.12% suspension (Prednefrin Forte) eye drops 3-Mar-21 3-Mar-21 There is a disruption to supply of Prednefrin Forte eye drops, anticipated to resolve on 1 Jan 2022. See Medication Safety Communication for further information Current
Pristinamycin (SAS) 500 mg tablets 14-May-20 24-Feb-21 Steady supply now available through Medsurge. Supplies through Link remain intermittent – ensure backorders are in place. Shortage resolved. Resolved
Olmesartan 27-Jul-20 24-Feb-21 Olmesartan MYL, Alphapharm and Sandoz brands 20 mg and 40 mg tablets are now available. Accord brand (UK) 40 mg olmesartan tablets available as S19A from Link Pharmaceuticals. Shortage resolved. Resolved
Adrenaline 1:10,000 19-Mar-20 24-Feb-21 Link and Juno (Aguettant) pre-filled syringe formulations available from wholesalers. Critical shortage of Link ampoules EXTENDED until 31 January 2021 (manufacturing issue) however there are ampoules available for ordering from Aspen. Hospitals are advised to put in a backorder with their preferred wholesaler. ACCESS TO NSW HEALTHSHARE STOCK WILL REMAIN OPEN FOR 1:10,000 AMPOULES – follow order process as distributed by HealthShare. If urgent requirement or problems submitting request, contact Noman.Masood@health.nsw.gov.au. Shortage resolved. Resolved
Tranylcypromine 21-Oct-20 24-Feb-21 Supply disruption of Parnate® has been extended until 31 January 2021. Emergency stock is available through Amdipharma. Both Amdipharma and Medsurge also have S19A products available (Packs of 100 tablets in a bottle compared to Australian registered product, 50 tablets in a blister). Shortage resolved Resolved
Morphine Sulfate - MS Contin (granules for) suspension 24-Feb-21 24-Feb-21 Production of all strengths of MS Contin (granules for) suspension, have been discontinued. Some strengths will be unavailable from March 2021, with a total run-out of stock anticipated by end of 2021. See Medication Safety Communication for further information. Current
Prazosin 24-Feb-21 24-Feb-21 Disruption to the supply of all brands and strengths of prazosin tablets. Estimated resolution dates between late November to late December 2020. Serious Shortage Substitution Notice was issue by the TGA in October. S19A alternative for all strengths (1 mg, 2 mg and 5 mg) available through Medsurge (Canadian brand with English packaging). Please note – S19A product must be protected from light. Shortage resolved Resolved
Phenelzine 15 mg tablet 17-Feb-21 17-Feb-21 The Australian registered medicine, NARDIL phenelzine 15 mg (as sulfate) tablet was discontinued on 2 April 2020. Supply of an alternative product, Phenelzine Sulfate USP 15 mg Tablets (Lupin Pharmaceuticals) is now available via LINK under Section 19A (S19A) of the Therapeutic Goods Act until 30 September 2021. The S19A product differs from NARDIL with respect to storage conditions (it does not require refrigeration) and its reduced pack size (60 tablets). The TGA previously issued a joint statement (https://www.tga.gov.au/sites/default/files/phenelzine-nardil-discontinuation.pdf) with the Royal Australian and New Zealand College of Psychiatrists and the Society of Hospital Pharmacists of Australia to provide advice for health professionals about accessing alternative products and patient management. Current
Dipyridamole/Aspirin 200 mg/25 mg modified release capsules 17-Feb-21 17-Feb-21 The Australian registered medicine ASASANTIN SR dipyridamole 200 mg/aspirin 25 mg sustained release capsules has been discontinued. The Australian registered medicine DIASP SR Dipyridamole/Aspirin 200 mg/25 mg modified release capsules is unavailable due to unexpected increase in demand. Supply of an alternative product, Aspirin and Extended-release Dipyridamole Capsules 25 mg/200 mg (USA), is available via Medsurge under Section 19A (S19A) of the Therapeutic Goods Act. Current
Fluoxetine 7-Oct-20 9-Feb-21 Prozac and APO fluoxetine 20mg tablets have been discontinued. Other brands of capsules and tablets are in short supply. Additional S19A alternatives with English packaging are available from Medsurge (capsules and tablets) and Link (capsules) until 30 April 2021. Please note the S19A Medsurge capsules and tablets come in bottles of 100 and 30 respectively. The S19A Link capsules come in a box of 30. (Compared to Australian registered product which is a 28-capsule or 28-tablet blister pack). The S19A Medsurge and Link tablets are not PBS listed. Current
Cisatracurium 21-Apr-20 5-Feb-21 Supply disruption to all strengths of Cisatracurium Juno has been resolved. Stock should be available through regular wholesalers. Resolved
Flucloxacillin 15-Dec-20 14-Jan-21 Supply disruption of Flubiclox® 1 g vials now resolved. Stock available at wholesalers. Resolved
Hydralazine 12-Jan-21 12-Jan-21 Anticipated shortage of LINK hydralazine hydrochloride 20 mg/1 mL solution for injection vial from 25 January 2021 to 14 May 2021. Apresoline powder for injection (ampoule presentation that requires reconstitution prior to use) unaffected at this stage. Current
Remdesivir 1-Jul-20 21-Dec-20 Correspondence from HealthShare NSW was sent to CEs of LHDs/SHNs on 18 December 2020. A copy of the procurement factsheet and post-marketing adverse event report can be found at the top of this page (see ‘Remdesivir information’ subsection). Please refer to the fact sheet for further information and direct any questions to Noman.Masood@health.nsw.gov.au. Current
Verapamil 5 mg/2 mL injection 23-Nov-20 18-Dec-20 Disruption to the supply of verapamil 5 mg/2 mL injection ampoules has been resolved. Resolved
Glyceryl trinitrate tablets 8-Dec-20 8-Dec-20 Anginine® 600 microgram tablet bottle was discontinued from the Australian market on 23 April 2020. Nitrostat® 300 microgram sublingual tablets are available through Pfizer under S19A until 31 January 2022. PLEASE NOTE – the difference in strength compared to the previous Australian registered product and that the S19A tablets must not be broken or halved. Current
Posaconazole 17-Nov-20 17-Nov-20 Noxafil® MR tablets and suspension will be delisted from the PBS on 1 December 2020. Whilst a generic alternative to the MR tablet formulation will be available on the PBS from this date (Juno brand), there is currently no sponsor that will be listing a suspension formulation. Facilities should consider the need to supply the suspension to outpatients from the hospital pharmacy following local DTC processes. Juno MR tablets are considered bioequivalent to the Noxafil® MR tablets. Current
Triamcinolone acetonide injection 29-Jun-20 17-Nov-20 Supply disruption resolved. Resolved
Desmopressin acetate 17-Nov-20 17-Nov-20 Disruption to the supply of Minirin® nasal spray and drop formulations with supply not anticipated before 2022. Alternate desmopressin formulations (tablets, sublingual wafers and injection ampoule) are unaffected. S19A alternative of nasal spray available through Medsurge (US brand with English packaging). Please note this product must be stored in an upright position and any solution remaining after 50 sprays must be discarded as the amount delivered thereafter may be substantially less than 10 micrograms of drug (S19A alternative contains 5 mL compared to the 6 mL in the Australian registered product). Current
Gentamicin 10 mg/1 mL 28-Apr-20 16-Nov-20 Safety communication has been updated to reflect extended resolution date and availability of additional S19A product that is a different strength to the Australian registered product (10 mg/2 mL compared to 10 mg/1 mL). Current
Gentamicin 80 mg/2 mL 13-Mar-20 4-Nov-20 Supply disruption to Australian registered product resolved. NOTE – S19A Hospira product contains the preservative, sodium metabisulphite, which is an irritant and may cause bronchoconstriction. Resolved
Isoprenaline 9-Oct-20 9-Oct-20 Safety information regarding S19A alternatives highlighted in 9 October 2020 communication. Current
Suxamethonium chloride 100 mg/2 mL 27-May-20 23-Sep-20 Australian registered product (Suxamethonium Juno) was released in September. This product is in a pack size of 10, presented in a glass ampoule and must be stored between 2-8 degrees Celsius. Juno also has S19A approval to import the Martindale brand (UK) of suxamethonium chloride. This product has a similar presentation to other Martindale products that may be kept in your facility (but is a different colour). A local risk assessment should be completed prior to ordering and use in your facility. Resolved
Methotrexate injection 16-Jul-20 18-Sep-20 Shortage of all affected strengths now resolved. Resolved
Amoxicillin/clavulanic acid IV injection 4-Jun-20 26-Aug-20 Shortage of Curam brand now resolved. Resolved
Dobutamine hydrochloride 250 mg/20 mL 15-May-20 26-Jun-20 Shortage of ARTG listed product now resolved. Please exercise caution if holding both DBL and S19A stock as they are different strengths. Resolved

The information is intended as a guide only and does not necessarily equate to expert opinion. The CEC does not endorse or recommend the use of any particular medication. Interpretation of recommendations should always be taken in context with the patient’s current condition and formal clinical assessment. Whilst the information is considered to be true and correct at the date of publication, changes in circumstances after the time of publication may impact on the accuracy of the information. The State of New South Wales is not in any way liable for the accuracy of any information printed and stored or in any way interpreted and used by a user.