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Recall of Instanyl 100mcg Nasal Spray Solution, Batch Number 447055 by Takeda UK Limited

 

The National Agency for Food and Drug Administration and Control (NAFDAC) has received information from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) that Takeda UK Limited is recalling Instanyl 100mcg nasal spray solution batch Number 447055. The recall is 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, the batch is being recalled as a precautionary measure 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.

Instanyl is indicated for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain.

Product details

The details of the affected product are as follows:

Product Company Name Batch number Expiry Date Pack Size First Distributed
Instanyl 100mcg Nasal Spray Takeda UK Limited 447055 31/10/2021 1 x 6 single dose containers 14/04/2020

 Recommendations

Healthcare providers are encouraged to:

  • Stop dispensing or distributing the above products immediately and quarantine the products.
  • Return unused products to the nearest NAFDAC office

Healthcare professionals are encouraged to report any adverse events or side effects related to the use of this product to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks), via the MedSafety App or via pharmacovigilance@nafdac.gov.ng

NAFDAC……..Customer-focused, Agency-minded!!!

Signed Management

 

NAFDAC

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