HPS Pharmacies wish to advise that multiple suppliers, in consultation with the Therapeutic Goods Administration (TGA), have initiated a drug recall for the following batches of quinapril products:
Quinapril GenericHealth 20mg (Batch: G106378)
APO-Quinapril 10mg & 20mg (All batches)
Acquin® 10mg & 20mg (All batches)
This recall is in addition to an earlier recall affecting Accupril® and Accuretic®, as follows:
| Accupril® 5mg:
· DJ3460 (Exp: 31 Dec 2022)
· DW5264 (Exp: 31 Dec 2022)
· EA0775 (Exp: 31 Dec 2022)
· EH5000 (Exp: 31 Dec 2022)
· EM1560 (Exp: 31 Dec 2022)
· EN3385 (Exp: 31 Dec 2022)
· ET1537 (Exp: 31 Dec 2022)
· FF2035 (Exp: 31 Dec 2022)
· FJ0767 (Exp: 31 May 2024)
· FM2032 (Exp: 31 May 2024)
|
Accupril® 10mg:
· EH4999 (Exp: 30 Jun 2023)
· FG9067 (Exp: 30 Jun 2023)
Accupril® 20mg:
· DM5047 (Exp: 31 Dec 2022)
· EA8252 (Exp: 31 Dec 2022)
· EP6759 (Exp: 30 Sep 2022)
· FM6631 (Exp: 30 Apr 2024) |
Accuretic® 10/12.5mg:
· DL8504 (Exp: 31 Jan 2023)
· EA7788 (Exp: 31 Jan 2023)
· EJ7130 (Exp: 31 Jan 2023)
· FD9321 (Exp: 31 Jan 2023)
· FH0042 (Exp: 31 Jul 2023)
Accuretic® 20/12.5mg:
· CA2054 (Exp: 31 Mar 2022)
· CK8051 (Exp: 31 Mar 2022)
· CR0338 (Exp: 31 Mar 2022)
· DC1449 (Exp: 31 Mar 2022)
· DX6315 (Exp: 31 Jan 2023)
· EX7673 (Exp: 31 Jan 2023)
· FE6833 (Exp: 31 Oct 2022)
· FJ1135 (Exp: 30 Apr 2024)
· FK8671 (Exp: 31 Aug 2024) |
This recall has been initiated following confirmation of the presence of the N-nitrosoquinapril impurity.
As a precautionary measure, sponsors of all marketed quinapril-containing tablets have paused supply while the issue is investigated. Patients should be advised to speak to their prescriber as alternative treatment options may be required. Further information on this issue can be found on the TGA website.
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 your pharmacist at HPS Pharmacies.
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HPS Pharmacies wish to advise that all suppliers are experiencing a supply interruption for trimethoprim products, as follows:
| Product |
ARTG |
Estimated return date |
|
Trimethoprim 300mg tablets
|
| Alprim® |
63518 |
Mid-January 2023 |
| Triprim® |
11009 |
Early March 2023 |
| Trimethoprim Viatris |
338350 |
Mid-January 2023 |
|
Trimethoprim + sulfamethoxazole
|
| Resprim® tablets (80mg/400mg) |
17681 |
Mid December 2022 |
| Resprim® Forte tablets (160mg/800mg) |
17682 |
Early February 2023 |
| Septrin® Forte tablets (160mg/800mg) |
10998 |
Late January 2023 |
| DBL™ Sulfamethoxazole 400mg and Trimethoprim 80mg/5 mL ampoule |
16293 |
Late February 2023 |
Internationally registered brands of trimethoprim 300mg tablets and sulfamethoxazole and trimethoprim 400mg/80mg ampoules have been approved for supply under Section 19A of the Therapeutic Goods Act 1989.
Septrin® Suspension (trimethoprim + sulfamethoxazole) is not currently affected by this supply interruption.
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 your pharmacist at HPS Pharmacies.
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Further to DrugAlert volume 803, HPS Pharmacies wish to advise that Eli Lilly is continuing to experience a supply interruption for Trulicity® as follows:
Trulicity® Pen
Dulaglutide (rch) 1.5 mg/0.5 mL
ARTG 16293
Eli Lilly has revised their expected return date to end-March 2023. An internationally registered brand of dulaglutide (rch) 1.5 mg/0.5 mL pens has been approved for supply under Section 19A of the Therapeutic Goods Act 1989.
For comprehensive information and updates, please go to the Trulicity (dulaglutide) shortage page available on the Therapeutic Goods Administration (TGA) website.
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 Eli Lilly on 1800 454 559 or your pharmacist at HPS Pharmacies.
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Further to DrugAlert volume 802, HPS Pharmacies wish to advise that Novo Nordisk is continuing to experience a supply interruption for Ozempic® as follows:
Ozempic® 0.25/0.5mg Pen
Semaglutide 1.34mg/mL
ARTG 308324
Ozempic® 1mg Pen
Semaglutide 1.34mg/mL
ARTG 315107
Novo Nordisk has revised their expected return date to end-March 2023. An internationally registered brand of semaglutide 0.25mg pens and semaglutide 1mg pens has been approved for supply under Section 19A of the Therapeutic Goods Act 1989.
For comprehensive information and updates, please go to the Ozempic (semaglutide) shortage page available on the Therapeutic Goods Administration (TGA) website.
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 Novo Nordisk on 1800 668 626 or your pharmacist at HPS Pharmacies.
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Further to DrugAlert volume 809, HPS Pharmacies wish to advise that all suppliers are continuing to experience a supply interruption for amoxicillin + clavulanic acid 875mg/125mg tablets, as follows:
| Product |
ARTG |
Estimated return date |
| AmoxyClav Generichealth 875/125 |
255076 |
Early March 2023 |
| APX-Amoxicillin/Clavulanic Acid |
351833 |
Early December 2022 |
| APO-Amoxy/Clav |
255080 |
End November 2022 |
| Augmentin Duo Forte |
54900 |
Early December 2022 |
| Curam Duo Forte |
198109 |
Mid-December 2022 |
An internationally registered brand of amoxicillin + clavulanic acid 875mg/125mg tablets has been approved for supply under Section 19A of the Therapeutic Goods Act 1989.
Oral liquids:
- Amoxicillin 125mg/5 mL + clavulanic acid 31.25mg/5 mL powder for oral liquid (Curam® Suspension) is now also unavailable with an estimated return date of late February 2023.
- Amoxicillin 400mg/5 mL + clavulanic acid 57 mg/5 mL powder for oral liquid is currently 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 your pharmacist at HPS Pharmacies.
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HPS Pharmacies wish to advise that AbbVie is discontinuing all Chirocaine® (levobupivacaine) products in Australia, as follows:
| Product |
ARTG |
Approximate discontinuation date |
| Chriocaine® 50mg/10ml ampoule |
76862 |
December 2022 |
| Chriocaine® 25mg/10ml ampoule |
76815 |
December 2022 |
| Chriocaine® 75mg/10ml ampoule |
76864 |
September 2023 |
| Chriocaine® 250mg/200ml bag |
94482 |
June 2023 |
No alternative brands of levobupivacaine are currently marketed in Australia.
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 AbbVie on 1800 043 460, or your pharmacist at HPS Pharmacies.
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Merck Healthcare has advised that Rebif® will be removed from the Pharmaceutical Benefits Scheme (PBS) from 1 December 2022. This affects the following products:
Rebif® Autoinjector
Interferon beta-1a 12 million units (44 mcg)/0.5 mL
ARTG 174479
Rebif® Pre-filled Syringe
Interferon beta-1a 12 million units (44 mcg)/0.5 mL
ARTG 133813
Rebif® Cartridge
Interferon beta-1a 36 million units (132 mcg)/1.5 mL
ARTG 165746
From 1 December 2022, PBS listings for the above products will be placed in a ‘Supply Only’ state until 31 March 2023 before being completely removed. During this period, these items can no longer be prescribed, but patients can continue to access outstanding repeats on prescriptions written prior to 1 December 2022.
Patients receiving treatment with Rebif® are encouraged to discuss their options with their treating specialist as soon as possible and before 31 March 2023, when their PBS prescription will no longer be valid.
Should you require further information regarding this matter, please contact Merck’s Medical Information Team on 1800 633 463 or via email at [email protected].
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HPS Pharmacies wish to advise that GlaxoSmithKline have discontinued Ortrivin® Nasal Drops as follows:
Otrivin® Adult Nasal Drops
Xylometazoline hydrochloride 1mg/mL
ARTG 142193
Otrivin® Junior Nasal Drops
Xylometazoline hydrochloride 0.5mg/mL
ARTG 142226
Otrivin® will still be available in the nasal spray presentation.
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 GlaxoSmithKline on 1800 028 533 or your pharmacist at HPS Pharmacies.
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HPS Pharmacies wish to advise that Perrigo Australia is experiencing a supply interruption for Phenobarbital Elixir as follows:
Orion Phenobarbital Elixir
Phenobarbital (Phenobarbitone) 15mg/5ml
ARTG 21187
This supply interruption is due to delays in the receipt of active pharmaceutical ingredient. Perrigo anticipates supplies to return in late January 2023.
If clinically appropriate, phenobarbital tablets could be considered as an alternative. The Don’t Rush to Crush handbook and MIMS Online provide advice on preparing and administering doses using crushed tablets.
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 Perrigo Australia on 1800 805 546 or your pharmacist at HPS Pharmacies.
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HPS Pharmacies wish to advise that Janssen-Cilag are planning to discontinue all Jurnista® prolonged-release tablets as follows:
Jurnista® Prolonged-Release Tablets
Hydromorphone hydrochloride 4mg
ARTG 155995
Jurnista® Prolonged-Release Tablets
Hydromorphone hydrochloride 8mg
ARTG 141508
Jurnista® Prolonged-Release Tablets
Hydromorphone hydrochloride 16mg
ARTG 141533
Jurnista® Prolonged-Release Tablets
Hydromorphone hydrochloride 32mg
ARTG 141534
Jurnista® Prolonged-Release Tablets
Hydromorphone hydrochloride 64mg
ARTG 141535
Discontinuation of supply will occur in Australia from 30 April 2023 (and/or until supplies are exhausted).
Janssen advises that the discontinuation of Jurnista® was a business decision and is not related to any safety, efficacy or quality issues.
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 Janssen on 1800 226 334, or your pharmacist at HPS Pharmacies.
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