Safety Alert On Molipaxin 100 Mg Capsules
The National Agency for Food and Drug Administration and Control has been informed that the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA), on 5th January, 2018, issued a safety alert on Molipaxin (Trazodone Hydrochloride) 100mg capsule manufactured by Winthrop Pharmaceuticals United Kingdom (UK) under the trademark, Zentiva. The safety alert was as […]
Ampicilin And Sulbactam For Injection Usp 1.5g/Vial By Auromedics: Recall -Presence Of Glass Particles In Vial
The National Agency for Food and Drug Administration and Control (NAFDAC) has been informed that AuroMedics Pharma is voluntarily recalling one lot of Ampicillin and Sulbactam for injection USP, 1.5g in a single -dose vial (equivalent to 1g ampicillin as the sodium salt plus 0.5g Sulbactam as the sodium salt) due to the presence of […]
Prescription Opioid Cough and Cold Medicine: FDA Requires Labeling Changes
The National Agency for Food and Drug Administration and Control has been informed by United States Food and Drug Administration that it is requiring safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone. Codeine and Hydrocodone are available in combination with other medicines, such as antihistamines and decongestants in prescription medicines […]
Circulation Of Fake Anti-Malaria Drugs
The National Agency for Food and Drug Administration and Control have been informed of the circulation of some fake varieties of anti-malaria drugs imported fraudulently from India. These products have been discovered to contain no active ingredients. The detail of the affected products are as follows: PRODUCT DESCRIPTION BATCH NUMBER Fansidar 25/500mg 29722 Combiart 20/120mg […]
Imodium (loperamide) for Over-the-Counter Use: FDA Limits Packaging to Encourage Safe Use
The National Agency for Food and Drug Administration and Control has been informed by the United States Food and Drug Administration that it is working with manufacturers of Imodium (loperamide) to use blister packs or other single dose packaging and to limit the number of doses in a package. This is to foster the safe […]
Gericare Eye Wash Kareway Products: Recall –Potential Product Contamination
The National Agency for Food and Drugs Administration and Control (NAFDAC) has been informed that Kareway Products Inc is recalling 60000 lots of Gericare Eye wash irrigation solution, 4 fluid ounces. The product has been found to have potential microbial contamination which compromises sterility. Use of the affected product could be calamitous for any population […]
Varubi (Rolapitant) Injection Emulsion: Anaphylaxis And Other Serious Hypersensitivity Reactions
The National Agency for Food and Drug Administration and Control (NAFDAC) has been informed by united states food and drug administration (FDA) that Anaphylaxis, anaphylactic shock and other serious hypersensitivity reactions have been reported in the post marketing setting, some requiring hospitalization. These reactions have occurred during or soon after the infusion of Varubi (rolapitant) […]
