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.

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. 

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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