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 [email protected]
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 [email protected]