Palmeux prolonged-release suspensions for injection in prefilled syringe, 50 mg, 75 mg, 100 mg, and 150 mg strengths, PA1142/040/002-005, Recall, all batches
02/01/2026
Medicines for human use
Recall
We wish to advise you that all in-date batches of Palmeux prolonged-release suspensions for injection in prefilled syringe, 50 mg, 75 mg, 100 mg, and 150 mg strengths are being recalled as a precautionary measure with immediate effect.
This recall is going to pharmacy level.
This recall is a precautionary measure due to GMP deficiencies identified at the manufacturing site.
The recall letters, dated 24th December 2025, can be downloaded in the Documents section at the bottom of this webpage.
Product information
- Product name
-
Palmeux 50 mg prolonged-release suspension for injection in prefilled syringe
Palmeux 75 mg prolonged-release suspension for injection in prefilled syringe
Palmeux 100 mg prolonged-release suspension for injection in prefilled syringe
Palmeux 150 mg prolonged-release suspension for injection in prefilled syringe - Authorisation holder
- Amdipharm Limited (trading as ADVANZ PHARMA Operations)
- Authorisation number
-
PA1142/040/002
PA1142/040/003
PA1142/040/004
PA1142/040/005
- Serial or batch number and expiry date
- All in-date batches
- Human or veterinary medicine
- Human medicine
- Target audience
- Wholesalers and pharmacies
- Recall level
- Pharmacy level
Actions to be taken
Information for Pharmacists
Pharmacists are requested to perform the following actions:
- Please immediately quarantine any units of these products which you have in your possession. For hospital pharmacies, this includes units at wards, clinics and any other relevant locations within the hospital.
- If you have supplied these products to any other pharmacy, clinic or other such healthcare establishment, please forward a copy of the recall letter (in the Documents section at the bottom of this page) to them, requesting that they immediately quarantine and return any unused units back to you.
- Return all quarantined units to your wholesaler.
Information for Wholesalers
Wholesalers are requested to perform the following actions:
- Immediately identify and quarantine any units of these products which you have in your facility or are returned to you by your customers.
- If you have supplied these products to any other wholesaler(s), please forward a copy of the recall letter (in the Documents section at the bottom of this page) to those wholesalers, requesting that they immediately quarantine any unsold quantities of these products and return those back to you.
- Return all quarantined units to your supplier.
Information for patients and public
No action is required by patients and public. If you have any of these products in your posession and you have any queries, please contact your pharmacist.