HPS Pharmacies wish to give notice that Fresenius Kabi, in consultation with the Therapeutic Goods Administration (TGA), has initiated a drug recall for Sodium Chloride 0.9% Freeflex bags as follows:
Sodium Chloride 0.9% Freeflex 100mL Injection Bag
Sodium chloride 900 mg/100 mL
ARTG 144609
The manufacturer is recalling one batch after identifying an issue where some Freeflex bags with the white injection port start leaking on withdrawal of the needle after injection.
The only affected batch is 82SG795105
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 Fresenius Kabi on 1300 732 001 or your pharmacist at HPS Pharmacies.
Download PDF
HPS Pharmacies wish to give notice that Viatris, in consultation with the Therapeutic Goods Administration (TGA), has initiated a product defect correction for Midazolam Alphapharm injection (now branded as Midazolam Viatris injection) as follows:
Midazolam Alphapharm
Midazolam 50 mg/10 mL
ARTG 160208
The only batch affected by this product defect correction is: F3138F02 (Exp 12/24)
This product defect correction is being undertaken due to the detection of a single ampoule of Urapidil Stragen 50mg/10ml in this batch of midazolam ampoules.
Please inspect your stock and quarantine any defect stock. 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.
Only cartons of Midazolam Alphapharm 50 mg/10 mL Injection that contain an ampoule of Urapidil Stragen are impacted by this event. If no Urapidil ampoules are contained, use of Midazolam Alphapharm from batch F3138F02 may continue.
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 Viatris on 1800 274 276 or your pharmacist at HPS Pharmacies.
Download PDF
Further to DrugAlert volume 885, HPS Pharmacies wish to provide an update on the availability of morphine oral solution. Ordine® Oral Solution is set to be discontinued, with all wholesale supplies expected to be exhausted by late March 2024.
However, the Therapeutic Goods Administration (TGA) has approved several overseas registered morphine oral solution products for supply under Section 19A of the Therapeutic Goods Act 1989. These products will be accessible from December 2023, when supplies of the lower strength Ordine® are expected to be depleted.
Products approved under Section 19A include:
- Morphine sulfate 2mg/mL oral solution (Hikma)
- Morphine sulfate 10mg/5mL oral solution (Martindale Pharma)
- Warning – this product contains ethanol (0.4mL per 5mL) and sucrose (2.25g per 5mL).
- Morphini HCl Streuli (morphine hydrochloride) 10mg/mL oral drops (Switzerland)
- Warning – this product is not labelled in English. Additional care is required when storing and dispensing this medicine. Appropriate auxiliary labels should be provided. Health professionals should refer to the Australian product information for dosing information.
- Warning – this product contains alcohol (1.2% v/v).
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 Mundipharma on 1800 188 009 or your pharmacist at HPS Pharmacies.
Download PDF
HPS Pharmacies wish to advise that Bayer Australia is experiencing a supply interruption for Mirena® as follows:
Mirena® IUD
Levonorgestrel 52mg
ARTG 73027
Normal supplies of Mirena® are expected to resume by early September 2023.
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 Bayer Australia on 1800 008 757, or your pharmacist at HPS Pharmacies.
Download PDF
HPS Pharmacies wish to advise that Pfizer is experiencing a supply interruption for lidocaine ampoules as follows:
Lignocaine Injection
Lidocaine (lignocaine) HCl 1% (50mg/5mL)
ARTG 49296
Lignocaine Injection
Lidocaine (lignocaine) HCl 2% (100mg/5mL)
ARTG 49293
Normal supplies of Pfizer Lignocaine Injection 1% are expected to return in early September 2023, with supplies of Pfizer Lignocaine Injection 2% expected to return by early October 2023.
Limited supplies of alternative products are available, including Lidocaine-Baxter 1% 5mL, Lidocaine Noridem 1% 5mL, and Lidocaine Juno 2% 5mL. The approved indications may vary between brands. Please consult the product information for further details.
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 Pfizer on (08) 93620666, or your pharmacist at HPS Pharmacies.
Download PDF
Further to DrugAlert volume 872, HPS Pharmacies wish to give notice that all manufacturers are continuing to experience a supply interruption for nizatidine capsules as follows:
| Product |
ARTG |
Expected date of return |
| Nizac® 150mg |
284129 |
Late October 2023 |
| Tacidine® 150mg |
94204 |
End July 2023 |
| Tazac® 150mg |
284130 |
Mid-December 2023 |
| Nizac® 300mg |
96963 |
Late October 2023 |
| Tacidine® 300mg |
94205 |
Mid-August 2023 |
| Tazac® 300mg |
49326 |
Late October 2023 |
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.
Download PDF
HPS Pharmacies wish to give notice that Sanofi-Aventis Australia, in consultation with the Therapeutic Goods Administration (TGA), has initiated a drug recall for Sabril® as follows:
Sabril® Tablets
Vigabatrin 500mg
ARTG 150021
Sabril® Powder
Vigabatrin 500mg
ARTG 52985
The only batches affected by this recall are:
- Sabril® tablets – Batch 2007A (expiry Nov 2025)
- Sabril® powder – Batch 2028C (expiry Mar 2025)
This drug recall is being undertaken as a precautionary measure following detection of an impurity that is a non-compliance to the product registration.
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.
Availability:
This recall has led to a supply interruption for Sabril® tablets and powder. Normal supplies of Sabril® tablets are expected to return in early August 2023; supplies of Sabril® powder are expected to return by mid-late September 2023.
During this supply interruption, Sanofi has a small amount of the 500mg powder oral sachets that will remain available for emergency supply for the treatment of infantile spasms (West Syndrome). To request access, please contact Sanofi Medical Information on 1800 818 806.
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 Sanofi-Aventis Australia on 1800 640 791 or your pharmacist at HPS Pharmacies.
Download PDF
Further to DrugAlert volume 884, HPS Pharmacies wish to provide an update on the anticipated availability of Ordine® Oral Solution following the announcement of its discontinuation.
| Product |
Run out month |
Expiry date |
| Ordine® 1mg/mL |
December 2023 |
31st March 2024 |
| Ordine® 2mg/mL |
February 2024 |
31st July 2024 |
| Ordine® 5mg/mL |
March 2024 |
31st July 2024 |
| Ordine® 10mg/mL |
March 2024 |
31st July 2024 |
It is expected that all wholesale supplies of Ordine® Oral Solution will be exhausted by April 2024.
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 Mundipharma on 1800 188 009 or your pharmacist at HPS Pharmacies.
Download PDF
HPS Pharmacies wish to advise that Mundipharma plans to discontinue Ordine® Oral Solution as follows:
Ordine® Oral Solution
Morphine hydrochloride trihydrate 1mg/mL
ARTG 150219
Ordine® Oral Solution
Morphine hydrochloride trihydrate 2mg/mL
ARTG 150220
Ordine® Oral Solution
Morphine hydrochloride trihydrate 5mg/mL
ARTG 150221
Ordine® Oral Solution
Morphine hydrochloride trihydrate 10mg/mL
ARTG 150222
The third-party manufacturer has decided to cease production of all Ordine® strengths due to commercial viability, with Mundipharma unable to source a substitute. Ordine® oral solution will cease to be available from early 2024.
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 Mundipharma on 1800 188 009 or your pharmacist at HPS Pharmacies.
Download PDF
HPS Pharmacies wish to advise that Arrow Pharma is discontinuing Capoten® Oral Liquid as follows:
Capoten® Oral Liquid
Captopril 5mg/mL
ARTG 68962
Capoten® Oral Liquid may still be available in some warehouses until current supplies are exhausted.
An internationally registered alternative has been approved for supply under Section 19A of the Therapeutic Goods Act 1989 until 30 April 2024. This product is identical to the Australian registered product for active ingredient and strength. However, there are some presentation differences, as shown in the table below.
| |
Capoten® |
S19A Product |
| Administration |
Give on empty stomach |
Give without regards to meals |
| Storage |
Refrigerate (2°C to 8°C) |
Do not store above 30°C |
| Expiry |
Discard 28 days after opening |
Discard 21 days after opening |
| Excipients |
Citric acid
Disodium edetate
Hydrochloric acid
Purified water
Sodium benzoate
Sodium citrate dihydrate
Sodium hydroxide |
Sodium benzoate (E211)
Citric acid monohydrate (E330)
Sodium citrate (E331)
Disodium edetate
Purified water |
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 Arrow Pharma on 1800 195 055 or your pharmacist at HPS Pharmacies.
Download PDF
