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