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Neupogen® 30 MU (0.3 mg/ml) Solution for injection filgrastim, PA 1026/001/001, Batch Recall

06/03/2025
Medicines for human use Recall

We wish to advise you that the below listed batches of Neupogen® 30 MU (0.3 mg/ml) solution for injection filgrastim are being recalled with immediate effect.

This recall is going to pharmacy level.

The recall letter can be downloaded in the Download section at the bottom of this webpage.

The reason for the recall is a stability issue whereby out of specification results for purity were detected at the 36-month (expiry) time point.
 

Product information

Authorisation holder
Amgen
Authorisation number
PA1026/001/001
Human or veterinary medicine
Human
Target audience
Pharmacists
Recall level
Pharmacy level

Actions to be taken

Information for Pharmacists

Pharmacists are requested to take the following actions:

  1. Immediately identify and quarantine any units of the below batches within your pharmacy. For hospital pharmacies, this includes units at wards, clinics and any other relevant locations within the hospital.
  2. If you have supplied these batches to any other pharmacy, clinic or other such healthcare establishment, please forward a copy of the recall letter to them, requesting that they immediately quarantine and return any unused units back to you.
  3. Return all quarantined units to your supplier indicating that the stock is returned as result of this recall action.

Information for patients and public

No action is required at patient level. If you have this medication in your possession and have any queries, please contact your pharmacist.

Suspected adverse reactions should be reported to gbinfoline@amgen.com and the Health Products Regulatory Authority (medsafety@hpra.ie)

 

 

 

Reference

Batch NumberExpiry Date
115675903 2025
116078310 2025
116971702 2026
117336505 2026

 

Documents

Opens in new window Neupogen_30_MU_Recall_Letter_Pharmacist PDF : 260KB | 06/03/2025