Public Alert No:007/2021 – Recall Of Phenylephrine Hydrochloride Injection Usp, 10mg/Ml By Sagent Pharmaceuticals Due To Potential Lack Of Sterility
, The National Agency for Food and Drug Administration and Control (NAFDAC) has been informed by U.S Food and Drug Administration that Sagent Pharmaceuticals is recalling three lots (PHT8IB2 PHT9IB2 PHT1JB2) of PHENYLEPHRINE HYDROCHLORIDE INJECTION USP, 10mg/ml due to potentially loose crimped vial overseals. A non-integral crimped vial overseal may result in a non-sterile product. […]
Public Alert No: 0010/2021 – Alert on Unregistered and Fake Insulin Tea for Diabetics
, The National Agency for Food and Drug Administration and Control (NAFDAC) wishes to notify the public of the circulation of an unregistered and fake product called Insulin Tea. Insulin Tea claims to reduce blood sugar level and ‘delete’ sugar in the body. Please note that the NAFDAC Number shown on the packaging of this […]
Public Alert No. 003/2021 – Recall of Hygiaflore Psyllium Bio Transit Capsule by Super Diet Laboratories
, The National Agency for Food and Drug Administration and Control has received information that the Directorate-General for Competition, Consumer Affairs and Fraud Control of France has warned the French public about the recall of Hygiaflore Psyllium Bio Transit Capsule, a plant based food supplement by Super Diet due to presence of Ethylene oxide. Ethylene […]
Public Alert No. 005/2021 – Malaysian Health Ministry Bans Some Cosmetic Products
, The National Agency for Food and Drug Administration and Control has received information that the National Pharmaceutical Regulatory Agency (NPRA) of the Malaysian Health Ministry has named some cosmetic products that have been found to contain prohibited substances, including unauthorized scheduled poisons in cosmetic products. The Products listed below are no longer allowed to […]
Covishield Vaccine Is Astrazeneca/Oxford University Vaccine
, AstraZeneca and Oxford University (AZOU) originally developed the ChAdOx1 recombinant adenoviral vector vaccine to be used for prevention of COVID-19 disease. AZOU gave the license of its vaccine to Serum Institute of India PVT Ltd (SIIPL) to manufacture this vaccine at commercial scale. SIIPL is the largest vaccine manufacturer in the world and the […]
Xeijanz, Xeijanz XR (tofacitinib): Initial Safety Trial Results Find Increased Risk of Serious Heart related Problems and Cancer with Arthritis and Ulcerative Colitis Medicines
, The National Agency for Food and Drug Administration and Control (NAFDAC) has been informed by U.S Food and Drug Administration about an increased risk of serious heart-related problems and cancer in relation to the use of the arthritis and ulcerative colitis medicine Xeijanz, Xeijanz XR (Tofacitinib) compared to another type of medicine called tumor […]
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 […]
Apotex Corp Recalls Enoxaparin Sodium Injection USP due to Mislabelling of Syringe Barrel Measurement Markings
, 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 […]
NAFDAC Approves ASTRAZENECA/OXFORD COVID-19 (COVISHIELD) VACCINE
, NATIONAL AGENCY FOR FOOD AND DRUG ADMINISTRATION AND CONTROL (NAFDAC) NAFDAC VACCINE COMMITTEE REVIEW OF ASTRAZENECA/OXFORD COVID-19 (COVISHIELD) VACCINE (SERUM INSTITUTE OF INDIA) RECOMMENDATION FOR EMERGENCY USE AUTHORIZATION PRESS BRIEFING FEBRUARY 18, 2021 1. INTRODUCTION The use of AstraZeneca/Oxford COVID-19 vaccine, a recombinant ChAdOx1 adenoviral vector encoding the structural surface glycoprotein […]
Public Alert No:002/2021 – Recall Of Sportmix Pet Food By Midwestern Pet Food Due To Potentially Fatal Level Of Aflatoxin
, The National Agency for Food and Drug Administration and Control (NAFDAC) has been informed that USFDA is alerting pet owners and veterinary professionals about certain Sport mix pet food products manufactured by Midwestern Pet Foods, Inc. in their Oklahoma plant that may contain potentially fatal levels of aflatoxins. Report reveals that more than 70 […]
