Knowledge Type: DrugAlert

Further to DrugAlert volume 778, HPS Pharmacies wish to advise that Aspen is experiencing a delay in the supply of the following non-autoclaved Marcain with Adrenaline 20mL product:

Marcain 0.5% with adrenaline 1:200,000 5 x 20 mL single dose vials

Bupivacaine + adrenaline (epinephrine)

ARTG 48329

An estimated date of supply is not yet available for the new non-autoclaved Marcain 0.5% with adrenaline 1:200,000 vials. However, a non-autoclaved alternative may be accessed through the special access scheme (SAS), if required.

The estimated return date for ‘Sterile Theatre Packs’ remains September 2022.

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 Aspen on 1300 659 646 or your pharmacist at HPS Pharmacies.

HPS Pharmacies wish to advise that Generic Health, in consultation with the Therapeutic Goods Administration (TGA), has issued a Product Defect Alert for Fentanyl GH 100mcg/2mL as follows:

Fentanyl GH

Fentanyl 100mcg/2mL

ARTG 201872

This notice was issued following a report of one box of Fentanyl GH 100mcg/2mL containing four ampoules of fentanyl and one ampoule of Heparin sodium 5000IU/1mL.

The only batch affected by this defect alert is batch 10450.

Generic Health advises healthcare professionals to open any boxes of Fentanyl GH 100mcg/2mL from this batch before dispensing to confirm that all five ampoules are the correct product.

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 Generic Health on (03) 9809 7900 or your pharmacist at HPS Pharmacies.

HPS Pharmacies wish to advise that Baxter is anticipating a supply issue for Elastomeric devices. Baxter has been monitoring this global issue and taking action to minimise supply interruptions of the following device:

Elastomeric Device LV-10 

Nominal Flow Rate 10mL/hour, 24 hour  

To further minimise customer impact, Baxter has imposed the following restrictions on the supply of compounded and non-compounded LV-10 devices:

• Total restriction of supply of non-compounded LV-10 devices
• Maximum order quantity of 10 pre-filled saline LV-10 devices
• Limited supply of compounded LV-10 devices greater than 7 days (with consultation).

These restrictions only affect the LV-10 device. The LV-5 device (5mL/hour) may be considered as an alternative.

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 1800 229 837 or your pharmacist at HPS Pharmacies.

Further to DrugAlert volume 778, HPS Pharmacies wish to advise that Aspen is also experiencing a supply interruption for Xylocaine 0.5% with Adrenaline ‘Sterile Theatre Packs’ as follows:

 

Xylocaine 0.5% with Adrenaline 5 x 20 mL vials

Lidocaine (lignocaine) + adrenaline (epinephrine)

ARTG 12008

 

Normal supplies of Xylocaine 0.5% with Adrenaline 20mL Vials are expected to be available in late September 2022.

 

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 Aspen on 1300 659 646 or your pharmacist at HPS Pharmacies.

HPS Pharmacies wish to advise that Aspen is now supplying Xylocaine with Adrenaline and Marcain with Adrenaline 20mL vials in a new presentation to replace ‘Sterile Theatre Packs‘ that have experienced supply issues. These new products are:

 

Xylocaine 1% with Adrenaline 5 x 20 mL single dose vials

lidocaine (lignocaine) + adrenaline (epinephrine)

ARTG 12015

 

Xylocaine 2% with Adrenaline 5 x 20 mL single dose vials

lidocaine (lignocaine) + adrenaline (epinephrine)

ARTG 12021

 

Marcain 0.25% with adrenaline 1:400,000 5 x 20 mL single dose vials

Bupivacaine + adrenaline (epinephrine)

ARTG 125878

 

Marcain 0.5% with adrenaline 1:200,000 5 x 20 mL single dose vials

Bupivacaine + adrenaline (epinephrine)

ARTG 48329

 

These new products have been introduced to minimise stock shortages of ‘Sterile Theatre Packs’. These products are supplied as non-autoclaved vials without the secondary packaging. The manufacturing process remains the same and the solution inside the vials is, of course, still sterile. However, these non-autoclaved vials should not be placed directly onto the sterile field in theatre.

 

It is anticipated that these new non-autoclaved packs will be available in mid-late April 2022 for Xylocaine with Adrenaline. New presentations of Marcain 0.25% with Adrenaline are expected in late April to early May 2022, with Marcain 0.5% with Adrenaline to follow in mid-May 2022.

‘Sterile Theatre Packs’ are expected to be available in September 2022.

 

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 Aspen on 1300 659 646 or your pharmacist at HPS Pharmacies.

 

HPS Pharmacies wish to advise that Pfizer, in consultation with the Therapeutic Goods Administration (TGA), has initiated a drug recall for DBL™ Vancomycin as follows:

DBL™ Vancomycin Vials

Vancomycin 500mg

ARTG 62603

This recall has been initiated following the return of out of specification stability results. Affected batches do not meet the shelf-life specification for potency or have atypically declining potency over the 30-month product shelf-life.

No adverse events or product complaints have been reported regarding these batches to date. However, Pfizer advises that there is a reasonable probability that use of impacted product towards the end of its shelf life may reduce its efficacy or contribute to the development of resistance.

The following batches are affected:

• H036913BA (Expiry 08-2022)
• H046913AA (Expiry 01-2023)
• H046913BA (Expiry 01-2023)
• H056913BA (Expiry 01-2023)

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 Pfizer on 1800 675 229 or your pharmacist at HPS Pharmacies.

 

 

 

Further to DrugAlert volume 768, HPS Pharmacies wish to give notice that Mundipharma is continuing to experience a supply interruption for Targin^® (oxycodone + naloxone) as follows:

Product	ARTG	Estimated return date
Targin® 2.5/1.25	216260	Late April 2022*
Targin® 5/2.5	156067	Available*
Targin® 10/5	156145	Available*
Targin® 15/7.5	216261	Available*
Targin® 20/10	156189	May 2022
Targin® 30/15	216280	Late April 2022*
Targin® 40/20	156194	To be confirmed
Targin® 60/30	243252	Available
Targin® 80/40	243272	Available

*Supply constrained by wholesaler

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 (02) 9231 7200 or your pharmacist at HPS Pharmacies.

HPS Pharmacies wish to advise that Sandoz is experiencing a supply interruption for modified-release oxycodone tablets as follows:

 

Oxycodone Sandoz Modified-Release Tablets

Oxycodone 5mg

ARTG 153605

 

Normal supplies of Oxycodone Sandoz 5mg modified-release tablets are expected to return in late April 2022. The Oxycontin^® brand is also experiencing a supply interruption of the 10mg presentation. However, alternative brands of 10mg modified-release oxycodone tablets are 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 Sandoz on 1800 726 369 or your pharmacist at HPS Pharmacies.

HPS Pharmacies wish to give notice that Phebra has changed the packaging of Sodium Chloride (0.9%) Injection as follows:

Sodium Chloride 0.9% Injection, 100mL

Sodium chloride 900mg/100mL

ARTG 48349

The colour band has been updated from blue to green, as shown in the new packaging below. Minor edits have also been introduced to align with Therapeutic Goods Order 91. The product formulation has not changed.

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.

Dear Valued Client,

 

HPS Pharmacies wish to give notice that Pfizer Australia is discontinuing Povidone-Iodine 10% w/v Solution Ampoules as follows:

 

Povidone-Iodine 10% w/v Solution Ampoule, 30mL

ARTG 12643

 

Povidone-Iodine 10% w/v Solution Ampoules will be discontinued on 1 July 2022. Supply has already been reduced and may be exhausted earlier than the discontinuation date.

 

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 Pfizer on 1800 675 229 or your pharmacist at HPS Pharmacies.