GovWire

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

Medicines Healthcare Products Regulatory Agency

October 23
09:48 2019

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. Pfizers 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.

Advice for healthcare professionals

Please quarantine all remaining stock of the above batches and return them to your supplier using yoursuppliers approved process.

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 deliveryaddress. Any product(s) returned from non-Pfizer accounts will be retained by the distribution center and not returned. Credit for these returned products must be obtained from the supplier from where the product was purchased.

Reporting of Suspected Adverse Reactions

You can assist us with monitoring the safety of Sayana Press 104mg/0.65ml by reporting suspected adverse reactions. Suspected adverse drug reactions (ADRs) should be reported via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Further Information

Pfizer is aware of the current supply constraints related to this product and is working diligently to resolve the issue and resume manufacturing.

If you have any questions in regards to return of stock, then please contact your local Alliance Healthcare Service Centre Customer Services team.

For medical information enquiries, please contact Pfizer Medical Information Department on +44 (0) 1304 616161.

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

Document

Class2 Medicine recall: Sayana Press

Published 23 October 2019

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