MHRA Company Led Drug Alert and Recall: Instanyl 100mcg nasal spray solution

MHRA Company Led Drug Alert and Recall: Instanyl 100mcg nasal spray solution

January 18, 2021

CLDA number: CLDA (21)A/01

Date issued: 18th January 2021

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a company-led drug recall for:

Instanyl 100mcg nasal spray solution

Product 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

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

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

For medical information enquiries, please contact: medinfoemea@takeda.com

For stock enquiries, please contact: allogaUK.credit.claims@alloga.co.uk

To view the alert please visit the GOV.UK website.

 



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