Class 2 Medicines recall: Sayana Press 104mg/0.65ml (MDR 055-06/19)

By 23rd October 2019 Other No Comments

Pfizer Ltd is recalling certain batches of Sayana Press for subcutaneous injection.

Product information

PL number

PL 00057 / 1093

MDR Number

MDR 055-06/19

Company name

Pfizer Limited

Product description

Sayana Press 104mg/0.65ml, medroxyprogesterone acetate suspension for injection (PL 00057 / 1093)

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

Brief description of the problem

Pfizer Ltd has informed us of an issue related to the sealing process for some units of Sayana Press for subcutaneous (SC) injection potentially impacting the above listed batches. Sayana Press for subcutaneous (SC) injection is provided in a single-dose Uniject pre-filled injection system. 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

The root cause analysis shows that the leak was attributed to a failure in the sealing process of the injection system and may impact the integrity of the product. Pfizer’s health assessment of the issue concluded that the use of the impacted product has an unlikely probability of being associated with adverse events and the potential risk to patients is considered to be negligible.


Source ~ MHRA