Class 2 Medicines recall: Sayana Press 104mg/0.65ml (Pfizer Ltd)

Class 2 Medicines recall: Sayana Press 104mg/0.65ml (Pfizer Ltd)

October 23, 2019

Drug alert number: EL (19)A/28

Date issued: 23 October 2019

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 2 medicines recall for:

Sayana Press 104mg/0.65ml Suspension For Injection (Pfizer Limited)

Pfizer Ltd has informed the MHRA of an issue related to the sealing process for some units of Sayana Press for subcutaneous (SC) injection potentially impacting some batches. During routine
re-inspection of unreleased product batches, two related defects were observed:

  • injectors with moisture outside the sealed area with a wet label, immediately after their removal from the pouch;
  • injectors with a temporarily unreadable expiry date on the unit label.

Action for pharmacy team 

Please quarantine all remaining stock of the following batches and return them to your supplier using your supplier’s approved process:

Batch Number Expiry Date Pack Size First Distributed
L61367 31 January 2020 1 10 April 2015
L61367Y 31 January 2020 1 02 May 2016
T34580 31 July 2020 1 08 November 2017
X49124 30 June 2021 1 09 October 2018

Pfizer say ‘Returns will be credited for all impacted product(s) against a Pfizer validated account up to a 12-week time frame from the start of the recall. No credits will be processed after the 12-week time frame from start of this recall. Please do not consolidate any stock for return. All returns must be from the original delivery address.’

View the full drug alert here.

Report suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

For returns queries contact your local Alliance Healthcare Service Centre Customer Services team.

For medical information enquiries contact Pfizer Medical Information Department 01304 616161.



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