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| The United Kingdom: Class 2 Medicines Recall: Sayana Press 104mg／0.65ml (English only) |
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The Medicines and Healthcare products Regulatory Agency (MHRA) announces that Pfizer Ltd is recalling 4 batches of Sayana Press 104mg/0.65ml, medroxyprogesterone acetate suspension for injection (batch number: L61367, L61367Y, T34580 and X49124).
Pfizer Ltd has informed MHRA of an issue related to the sealing process for some units of Sayana Press for subcutaneous injection potentially impacting the above listed batches. Sayana Press for subcutaneous 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.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-2-medicines-recall-sayana-press-104mg-0-65ml-mdr-055-06-19
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Thursday, Oct 24, 2019
Issued at HKT 16:00
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