Recalls & Alerts Published by NAFDAC
The attention of the Agency has been drawn to the FDA’s alert to physicians who care for pregnant women meeting CDC Zika virus clinical criteria and/or CDC Zika virus epidemiological criteria, that the U.S. commercial testing facility, Laboratory Corporation of America (LabCorp). It has been reported that some false positive results from the ZIKV Detect test. The FDA has not yet determined if the reported false positives are related to the ZIKV Detect test or the commercial testing facility. While the FDA has not yet determined if the reported false positives are related to the ZIKV Detect test or the commercial testing facility, it is important to remember that IgM tests remain useful in ruling out Zika exposure but require confirmatory testing.
The ZIKV Detect IgM Capture ELISA is used for the preliminary (presumptive) detection of Zika virus IgM antibodies in human sera collected from patients with a history of clinical signs and symptoms associated with Zika virus infection (Centers for Disease Control and Prevention [CDC] clinical criteria for Zika virus) and/or a history of residence in or travel to a geographic region with active Zika transmission at the time of travel (CDC Zika virus epidemiological criteria).
Healthcare providers’ action
Inform their patients that presumptive positive results need to be confirmed, so that pregnant women are not making health care decisions based on incomplete information.
Don’t rely on presumptive positive Zika virus IgM test results as the sole basis of significant patient management decisions.
Notify the laboratory of the patient’s pregnancy to facilitate prioritization of confirmatory testing by CDC or disqualified laboratories.
The attention of the agency has been drawn to the recall of a batch of Hydrocortisone injection as a precaution following the receipt of a number of complaints that the solution in some ampoules has a yellowish appearance. Hydrocortisone injection is used to treat symptoms of low corticosteroid levels (lack of certain substances that are usually produced by the body and are needed for normal body functioning). It is also used to treat severe allergic reactions. Hydrocortisone injection is used in the management of multiple sclerosis (a disease in which the nerves do not function properly), lupus (a disease in which the body attacks many of its own organs), gastrointestinal disease, and certain types of arthritis. It is also used to treat certain conditions that affect the blood, skin, eyes, nervous system, thyroid, kidneys, and lungs. Hydrocortisone injection is in a class of medications called corticosteroids. It works to treat people with low levels of corticosteroids by replacing steroids that are normally produced naturally by the body. It also works to treat other conditions by reducing swelling and redness and by changing the way the immune system works.
Name of Product: Hydrocortisone Injection
Affected Batch No: 039268
Expiry date: August 2017
Healthcare Provider’s action
Healthcare provider should quarantine any offending ampoules
NAFDAC………Safeguarding the Health of the Nation!!!
The attention of the National Agency for Food and Drug Administration and Control (NAFDAC) has been drawn to the recall of three brands of Fleming pharmaceutical products on November 14, 2016 by the Hong Kong Department of Health (DH) over misinformation of the package label instruction which do not match with the registered version, thereby rendering the products unregistered and unsafe for human consumption. The products which contained amoxicillin and clavulanic acid were supplied by Hong Kong-based Medreich Pharmaceutical franchise, Medreich Far East Limited.
THE RECALLED PRODUCT DETAILS:
|PRODUCT NAME||REGISTRATION NUMBER|
|Fleming Tablets 1g||HK- 52242|
|Fleming for oral suspension 457mg/5m||HK- 56072|
|Fleming for suspension 228.5mg/5ml||HK- 56069|
HEALTHCARE PROVIDER’S ACTION
- Healthcare providers and patients in possession of these affected products should stop using them.
NAFDAC........Safeguarding the Health of the Nation!!!