Palmeux 75 mg and 150 mg prolonged-release suspension for injection – PA1142/040/003, 005 – One batch each

We wish to advise you that one batch of Palmeux 150 mg prolonged-release suspension for injection in prefilled syringe and one batch of Palmeux 75 mg prolonged-release suspension for injection in prefilled syringe is being recalled with immediate effect.

This recall is going to pharmacy level.

Problem or issue

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

Copies of the recall letters are provided in the Documents section below.

Actions to be taken

Information for pharmacists

Pharmacists are requested to take 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.

Documents