The HPRA have advised that one batch of Palmeux 150mg prolonged-release suspension for injection in prefilled syringe (PA1142/040/005, batch no. 4200980, expiry date 11/2024) and one batch of Palmeux 75mg prolonged-release suspension for injection in prefilled syringe (PA1142/040/003, batch no. 4300693, expiry date 08/2025) are being recalled with immediate effect.
The 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.
You are requested to take the following actions:
- 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.
- Please return all quarantined stock to the wholesaler from whom you received it.
- 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.
A copy of the recall letter can be downloaded here.
