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.
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.