Nigerian News | NAFDAC Recall Instanyl 100mcg Nasal Spray Solution by Takeda UK Limited

NAFDAC OFFICE
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The National Agency for Food and Drug Administration and Control (NAFDAC) has received information from the U.K. 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 an inspection of the bulk vials and release testing of the finished products.

The agency reportedly said that 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 the 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

The agency encouraged healthcare providers to stop dispensing or distributing the above products immediately and quarantine the products and return unused products to the nearest NAFDAC office.

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About Nathaniel Adebayo 689 Articles
Nathaniel is a News Reporting Intern at Nigerian Law Intellectual Property Watch (NLIPW). He has a passion for writing, capacity building and social media marketing. He is a graduate of Federal University of Technology, Minna, where he graduated with BTECHAGRIC. He is a member of Soil Science Society of Nigeria (SSSN) and the National Union of Campus Journalist (NUCJ). Nathaniel has served as Editor-in-Chief for a number of magazines and as a contributor to various online repositories. Email: anathaniel@nlipw.com

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