Manufacturers’ alerts

 

The following is information that SHPA has received from manufacturers of medicines, such as alerts regarding supply problems, discontinued items etc. that may be useful to SHPA members.

Other resources:

  • TGA Medicine Shortages Information Initiative which provides up-to-date information about temporary or permanent disruption (discontinuation) to the supply of a medicine in Australia. You can also subscribe to updates so you will receive an email when there is a new or updated medicine shortage reported by sponsors to the TGA and published on the Medicine Shortages Information website. 
  • TGA Australian Recall Actions for recalls of medicines, medical devices and biologicals.
  • TGA Alerts which advises consumers, health professionals and industry about new safety information regarding therapeutic products.

HEPARIN SODIUM 5000 IU/5 mL ampoule shortage
12 July 2018

LINK advises that due to a shortage of the Australian registered DBL HEPARIN SODIUM (porcine mucous) 5000IU/5mL injection ampoule (AUST R 49232), LINK has arranged the supply of Heparin sodium 1,000 I.U./mL solution for injection or concentrate for solution for infusion, 5mL ampoules (5,000 I.U./5mL) registered and marketed in the United Kingdom. 

TOFRANIL, imipramine hydrochloride 25mg tablets
1 July 2018

TOFRANIL, imipramine hydrochloride 25 mg tablets, AUST R 60673, LINK has arranged the supply of an alternative product currently registered in Germany.  This product is Imipramin-neuraxpharm 25 mg and supply is authorised under an exemption grated by the TGA under section 19A of the Therapeutic Goods Act (1989) until 30 September 2018.

ISUPREL isoprenaline hydrochloride 200 micrograms/1mL injection ampoule shortage

26 June 2018

Orpharma advises that due to the shortage of Australian registered ISUPREL isoprenaline hydrochloride 200 microgram/1mL injection ampoule, the supply of an alternative product has been arranged. Orpharma will supply ISOPRENALINE HYDROCHLORIDE MONICO 0.2mg/1mL solution for injection ampoule, registered and marketed in Italy.  

HEPARINISED SALINE 50IU/5ml ampoule

19 June 2018

LINK advises that due to a shortage of the Australian registered HEPARINISED SALINE 50IU/5mL (porcine mucous) 50IU/5mL injection ampoule (AUST R 66684). INK can supply Heparin Sodium 10 I.U./mL flushing solution for maintenance of patency of intravenous devices (50 I.U. in 5mL) registered and marketed in the United Kingdom.

Marcain®, Xylocaine and Naropin Shortage - updates on shortages

8 June 2018 

Aspen Pharmacare advises there is a shortage of Marcain, Xylocaine and Naropin due to a fire at AstraZeneca's Swedish manufacturing site with supply expected to recommence from Quarter 3 2018 onwards. 

AZACTAM (aztreonam) 1g Powder for injection shortage

11 May 2018

Bristol Myers Squibb Australia advises that due to a manufacturing issue at the active substance manufacturing plance there is a shortage of AZACTAM (aztreonam) 1g powder for injection. Current stock is likely to be depleted by 25 May 2018 with partial re-supply by mid-June. BMS recommends all health care providers prioritise aztreonam for patients they feel are in the greatest need with no other alternative.

HEPARIN SODIUM 5000 IU/0.2 mL ampoule shortage
20 April 2018

LINK advises that due to a shortage of the Australian registered DBL HEPARIN SODIUM (porcine mucous) 5000IU/0.2mL injection BP ampoule (AUST R 16349), LINK has arranged the supply of HeparinNatrium-5000-ratiopharm, heparin sodium 5000 IU/0.2 mL ampoules registered and marketed in Germany and supply is granted under an exemption granted by the Therapeutic Goods Administration under Section 19A of the Therapeutic Goods Act, 1989 until 15 October 2018. 

Phenobarbitone tablets 30mg 200 delay

17 April 2018

Arrow Pharmaceutical advises that due to manufacturing capacity constrains, deliver of Phenobarb tablets 30mg 200 is not expected until early June 2018. 

DANTRIUM® powder for injection 20mg vials

8 February 2018

Pfizer advises there is a shortage in Dantrium® powder for injection 20mg vials and supply of an alternative product Dantrium® Intravenous 20mg powder for solution for injection (Norgine) has been arranged on a temporary basis. 

Chlorhexidine injection risks

January 2018

The Australian and New Zealand College of Anaesthetists and the Australian Commission on Safety and Quality in Health Care have developed a safety statement in response to reported incidents of accidental injection of chlorhexidine, a surface disinfectant.  

DBL™ Metronidazole Intravenous Infusion 500mg in 100mL bag

8 January 2018

Pfizer advises that batch 70094/March 2019 of DBL™ Metronidazole Intravenous Infusion 500 mg in 100 mL infusion bags are being recalled based on a customer report that a single unit from a 10 unit box had visible black particles reported as mould between the infusion bag and plastic overwrap.

 
2017 Manufacturers' Alerts

Methylprednisolone acetate Suspension for Injection 40mg per mL

12 December 2017 

Pfizer advises there is an interruption to supply for DEPO-NISOLONE™ Injection 40mg per mL and there will be an interruption to the supply of DEPO-MEDROL™ Injection 40mg per mL from late January 2018, due to unexpected manufacturing delay. 

DBL™ Diazepam Injection 10mg/2ml ampoules

28 November 2017

Pfizer advises there is an interruption in supply for DBL™ Diazepam Injection 10 mg/2ml ampoules, due to an unexpected manufacturing delay. Judicious use of ampoules is recommended during the current constraints on supply and use should be reserved where no therapeutic alternatives are available.

Hydroxyurea

22 November 2017

Bristol Myers-Squibb advises there is a global shortage of supply of HYDREA hydroxycarbamide (hydroxyurea) and that stocks will be depleted by early December 2017. It is expected that supply will be re-instated by 15 January 2018. 

Methotrexate Injection BP 50mg/2 mL vial shortage

15 November 2017

Pfizer advises there is an interruption in supply for Methotrexate Plastic Cytosafe Vial 50 mg/2mL (Pfizer) and DBL™ Methotrexate Injection BP  50 mg/2 mL vial, due to an unexpected manufacturing delay. 

Pamisol 15mg/5mL vial and 90mg/10mL injection vial shortage

15 November 2017

Pfizer advises there is an interruption in supply for Pamisol (disodium pamidronate) 15mg/5mL and 90mg/10mL injection vials, due to unexpected manufacturing delay. 

Methotrexate Injection BP 50mg/2 mL vial shortage

26 October 2017

Pfizer advises there is an interruption in supply for Methotrexate Plastic Cytosafe Vial  50 mg/2mL (Pfizer) and DBL™ Methotrexate Injection BP  50 mg/2 mL vial, due to an unexpected manufacturing delay.  

Cytarabine Injection 2g in 20 mL vial and Vincristine Sulfate Injection 2mg in 2mL vial shortage
23 October 2017

Pfizer advises there is an interruption in supply for Cytarabine Injection 2g in 20 mL vial and Vincristine Sulfate Injection 2mg in 2mL vial, due to an unexpected manufacturing delay. 

Gentamicin Injection BP 80 mg in 2 mL Steriluer® - Product recall
6 October 2017

Pfizer advises that, following an internal investigation, ten batches of Gentamicin Injection BP 80 mg in 2 mL Steriluer® are being recalled as they may contain a higher than expected intrinsic constituent (histamine) in the finished product. View recall notice.

Dexamethasone sodium phosphate shortage
1 May 2017

TGA updated medicine shortage information.

Phenoxybenzamine hydrochloride shortage
1 May 2017

TGA updated medicine shortage information.

DANTRIUM (dantrolene sodium) Powder for Injection 20 mg- Updates on shortage
7 April 2017

Pfizer advises there is an interruption in supply for Dantrium (dantrolene sodium) powder for injection 20mg, due to an unexpected manufacturing delay.
Previous notice.

EpiPen 300 microgram adrenaline injection syringe auto-injector
20 March 2017

The TGA has issued recall for four batches of the EpiPen 300 microgram adrenaline injection syringe auto-injector. EpiPens from affected batches can be returned to pharmacies for a refund or exchanged for one from a different, unaffected batch free of charge.

Etopophos (etoposide phosphate) powder for injection vials and Vepesid etoposide capsules
14 February 2017

The TGA have announced that there are current shortages of Etopophos etoposide 1 g (as phosphate) and Etopophos etoposide phosphate 113.6 mg (equivalent to 100 mg etoposide) powder for injection vials and Vepesid etoposide 50 mg capsule blister packs. The Vepesid etoposide 100 mg capsule blister pack shortage has been resolved.

Glyceryl trinitrate tablets (Anginine and Lycinate) potential medicine shortage and alternative product
9 February 2017

The TGA have announced that following the potential shortage of glyceryl trinitrate tablets due to reformulation, an alternative supply (Nitrostat tablets) has now been approved. Please note that the TGA anticipate a shortage for the alternative product 600 mcg (0.6 mg) of Nitrostat tablets.

Metformin tablet shortage — Updates on availability
19 January 2017

The TGA has released a statement advising consumers and health professionals about a change in status in the availability of metformin extended release tablets.

Stonefish Antivenom 2000U Injection Vial
10 January 2017

Seqirus advises that Stonefish AV Lot 056007501 has 2.52 mL product volume, instead of the volume of 2.29 mL. 

 
2016 Manufacturers' Alerts

Urgent recall for Dilantin

5 December 2016

Pfizer issued a recall of dilantin (phenytoin sodium) 30 mg capsule bottle, 100 mg capsule bottle and dilantin (phenytoin) infatabs 50 mg tablet bottle.  

Discontinuation of Modecate (fluphenazine decanoate) injection
1 December 2016

Bristol Myers Squibb advise that they will cease supply of Modecate (fluphenazine decanoate) injection and expect supply to be depleted between March and August 2017. The information is also available via the TGA website.

Supply information regarding Etopophos inj (etoposide phosphate),Vumon inj (teniposide) and Vepesid (etoposide) 
25 November 2016

Bristol Myers Squibb have released updates in the supply of three medicines. Etopophos inj (etoposide phosphate) remains out of stock. Vumon inj (teniposide) is to cease supply due to the end of global production and Vepesid (etoposide) 50mg capsules are in short supply, with the next shipment expected to arrive mid-December 2016. Update: Vepesid (etoposide) 50mg capsules are still in short supply.

Aciclovir 250 mg/10 mL injection anticipated shortage
11 November 2016

Medicine shortage information about aciclovir injection has been posted on the TGA website.

Carbimazole Manufacturing Delays
6 October 2016

Link Healthcare has issued a notification to address the shortage of Australian registered carbimazole 5mg tablets. Link has been granted TGA approval to supply German registered Carbimzol Aristo 5mg tablets.

Angiomax (bivalirudin) updated safety information
1 October 2016

The Medicines Company issued a letter to inform of updates in important new safety information regarding contraindications, precautions, dosage and administration of angiomax (bivalirudin).

Recall for GlucaGen HypoKit
12 September 2016

The TGA has released a statement regarding their decision to recall four batches of the GlucaGen HypoKit. It has been identified that a small number of GlucaGen HypoKits have needles which may become detached from the pre-filled syringes. Patients who return affected products will be given free replacements.

Recall for APO-Cabergoline
2 September 2016

The TGA has released a statement regarding Apotex and their decision to recall one batch of APO-Cabergoline 500mcg tablets due to a packaging issue, which could potentially lead to the product degrading over time in moist conditions.   

Safety alert for Actilyse (alteplase)
22 August 2016

Boehringer Ingelheim has issued a safety alert regarding an issue during reconstitution of Actilyse (alteplase (rch)) 50 mg powder for injection. Boehringer Ingelheim emphasises the importance of strict compliance with handling instructions provided on the packaging of the transfer cannula.

Monoplus and Monopril discontinuation
22 August 2016

Bristol-Myers Squibb has issued a letter regarding the decision to discontinue Monoplus 10mg (fosinopril 10mg and hydrochlorothiazide 12.5mg), Monoplus 20mg (fosinopril 20mg and hydrochlorothiazide 12.5mg) and Monopril 20mg (fosinopril 20mg) tablets in Australia.

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