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Day: 19 February 2021

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

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

NEWS
  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 p...
Apotex Corp Recalls Enoxaparin Sodium Injection USP due to Mislabelling of Syringe Barrel Measurement Markings

Apotex Corp Recalls Enoxaparin Sodium Injection USP due to Mislabelling of Syringe Barrel Measurement Markings

NEWS
  The National Agency for Food and Drug Administration and Control (NAFDAC) has received information from the US FDA that Apotex Corp is voluntarily recalling two (2) batches of Enoxaparin Sodium Injection, USP due to a packaging error resulting in some syringes barrels containing 150 mg/mL markings (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength) on the syringe barrel and vice versa. Enoxaparin Sodium injection is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), Treatment of Acute Deep Vein Thrombosis, prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin and Treatment of Acute...
WHO Urges COVID-19 Vaccine Manufacturers to Uphold Pledges

WHO Urges COVID-19 Vaccine Manufacturers to Uphold Pledges

NEWS
The World Health Organisation on Thursday urged COVID-19 vaccine manufacturers to make good on their commitments as the planet’s poorest countries await their first doses. WHO Director-General, Tedros Adhanom Ghebreyesus said the Covax facility – the global COVID-19 vaccine procurement and distribution effort ensuring poorer countries can access doses – was now ready to begin vaccine distribution. Around 336 million AstraZeneca-Oxford doses and 1.2 million Pfizer-BioNTech doses – the only two vaccines with WHO approval – are set to start being shipped out later this month through Covax. “At the beginning of the year, I issued a call to action to ensure that vaccination of health workers was underway in all countries within the first 100 days of the year,” Tedros told a news co