Company led medicines recall: Instanyl 100mcg nasal spray solution (EU/1/09/531/015)

Takeda UK Limited is recalling a batch of Instanyl 100mcg nasal spray solution (EU/1/09/531/015) due to the observation of cracked vials during inspection of the bulk vials and release testing of the finished products.

CLDA Number

CLDA (21)A/01

MDR Number

MDR 111-01/21

Company Name

Takeda UK Limited

Product description

Instanyl 100mcg nasal spray solution in single-dose container (EU/1/09/531/015)

Lot Number/ Expiry

Product name Batch Number Expiry Date Pack Size First Distributed
Instanyl 100mcg Nasal Spray 447055 31/10/2021 1 x 6 single dose containers 14/04/2020

Brief Description of Problem

Takeda UK Limited is recalling the above batch of Instanyl 100mcg nasal spray solution (EU/1/09/531/015) due to the observation of cracked vials during inspection of the bulk vials and release testing of the finished products. So far, the company has not received any reports of damage for the marketed products. However, due to the low potential for breaking or cracking of the glass vial, which is contained within the plastic actuator casing and a potential risk of microbial contamination, the above batch is being recalled as a precautionary measure.

Company Contact for medical information enquiries

For medical information enquiries, please contact: Takeda UK Limited by emailing medinfoemea@takeda.com

Company Contact for stock enquiries

Remaining stock of these batches should be quarantined and returned to Takeda for replacement stock where available.

For stock information enquiries, please contact: Alloga UK by emailing allogaUK.credit.claims@alloga.co.uk

Updates to this page

Published 18 January 2021