Recall notice for one batch of Palmeux 150 mg prolonged-release suspension for injection in prefilled syringe, PA1142/040/005 and one batch of Palmeux 75 mg prolonged-release suspension for injection in prefilled syringe, PA1142/040/003

Notice type: Recall

Date: 28/06/2024

We wish to advise you that one batch of Palmeux 150 mg prolonged-release suspension for injection in prefilled syringe (batch no. 4200980, expiry date 11/2024) and one batch of Palmeux 75 mg prolonged-release suspension for injection in prefilled syringe (batch no. 4300693, expiry date 08/2025) are being recalled with immediate effect.

This recall is going to pharmacy level.

The reason for the recall is that the impacted batches displayed out of specification results for particle size distribution.

The attached recall letters provide additional information in relation to this issue:
Pharmacy Recall Letter
Wholesaler Recall Letter



Product name or type:
Palmeux 150 mg prolonged-release suspension for injection in prefilled syringe, PA1142/040/005 and Palmeux 75 mg prolonged-release suspension for injection in prefilled syringe, PA1142/040/003


Authorisation Number:
PA1142/040/005 and PA1142/040/003


Serial Or Batch Number And Expiry Date:
Palmeux 150 mg prolonged-release suspension for injection in prefilled syringe, PA1142/040/005: Batch no. 4200980, expiry date 11/2024

Palmeux 75 mg prolonged-release suspension for injection in prefilled syringe, PA1142/040/003: Batch no. 4300693, expiry date 08/2025


Authorisation Holder:
Amdipharm Limited (trading as ADVANZ PHARMA Operations)


Prescription Required:
Yes


Actions To Be Taken:
Pharmacists are requested to please carry out the following actions:

1. Immediately quarantine any units of the above-listed batches which you have in your possession. For hospital pharmacists, this includes stock on wards, at clinics or any other location within your hospital.
2. Please return all quarantined stock to the wholesaler from whom you received it. 
3. If you have supplied the above-listed batches to any other pharmacy, clinic or other such establishment, please provide them with a copy of the recall letter.

Unaffected stock of Palmeux 150 mg prolonged-release suspension for injection in prefilled syringe is currently available to order. No replacement stock of Palmeux 75 mg prolonged-release suspension for injection in prefilled syringe is currently available to order.

Information for patients:
No action is required at patient level; however, if you have any concerns, please contact your pharmacist.


« Back