The manufacturing, importation and distribution of substandard pharmaceutical products in Nigeria is not a new trend. Below is the List of Fake and Substandard Drugs in Circulation in Nigeria.
But the number of life lost through the use of these products have can not be substantiated. In line with the mandate of safeguarding the health of the nation, the National Agency for Food and Drug Administration and Control (NAFDAC) have been vigilante in monitoring the sharp practices experienced in these area.
Therefore the attention of the agency has been drawn to the recall of the following products:
1. Hydrocortisone 100mg/1 ml solution
The recall of the Hydrocortisone injection is 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
2. Fentanyl Citrate Injection
The recall of Fentanyl Citrate Injection, 50mcg/mL was over confirmed ampoules with broken tips.
Fentanyl is a potent, synthetic opioid pain medication with a rapid onset and short duration of action. It is a potent agonist at the μ-opioid receptors.
Fentanyl Citrate Injection is indicated as short-term analgesia during anaesthetic periods, premedication, induction and maintenance and as an analgesic supplement in general or regional anaesthesia. Fentanyl Citrate is used for intravenous (IV) or intramuscular (IM) use.
- NAME– Fentanyl Citrate Injection 50mcg/mL
# Affected Lot Numbers: 59277EV, 60028EV
- EXPIRY DATES- 1st November 2017, 1st December 2017.
3. Three Brands Of Fleming Pharmaceutical Products
Fleming pharmaceutical products on November 14, 2016 was recalled 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|
4. Falsified Quinine Sulphate 300mg
The circulation of two confirmed falsified Quinine Sulphate 300mg tablet versions in Cameroon and the Democratic Republic of Congo has been confirmed by the agency. The products have been found to contain zero active pharmaceutical ingredients.
Quinine Sulphate is an anti-malaria drug used for the treatment of Plasmodium falciparum Malaria. These falsified products were first discovered by a local NGO on failing field screening.
They were submitted to a WHO pre-qualified Quality Assurance Laboratory and subsequent analysis from the laboratory showed neither of the products contained any of the stated active ingredients.
The details of the falsified products are;
|Product 1||Product 2|
|Product Name: Quinine Sulphate 300mg
Manufacturer: Novadina Pharmaceutical Ltd,
London, United Kingdom
Number of tablets per container: 1000
Batch Number: 10H05
Date of Manufacture: 09/2014
Expiry date: 09/2018
|Product Name: Quinine Sulphate 300mg
Manufacturer: CAD Pharm, India
Number of tablets per container: 100
Batch Number: F4387
Date of Manufacture: 12/14
Expiry date: 11/18
NAFDAC implores importers, distributors, retailers and the general public to ensure vigilance and avoid the purchase of the confirmed falsified products.
HEALTHCARE PROVIDER’S ACTION
Healthcare providers and patients in possession of these affected products should stop using them.
Importers, distributors, retailers and the general public are to ensure vigilance and avoid the purchase of the confirmed falsified products.
All distributors, retailers and members of the public with these falsified products should submit products to the nearest NAFDAC office for distruction.
Healthcare providers and patients are encouraged to report adverse events associated with the use of these products to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks) or via firstname.lastname@example.org