Recalls & Alerts Published by NAFDAC

The Agency have been notified of the recall of three (3) lots of intravenous solution by the Singaporean Health Science Authority (HSA). The recall was due to leakages and particulate issues which could contaminate the solution and possibly result to infection in the bloodstream, health hazards such as stroke, heart attack, damages to key organs like the kidney or liver, and even death.

Details of the affected lots are as follows:

Product code:              2B3421

Product Description:  Metronidazole Injection, USP, 500mg/100mL

Lot Number:                P339135

Expiration date:          31/08/2017

NDC :                             0338-0553-48  

Product code:              2B0043

Product Description:  0.9% Sodium Chloride Injection, USP, 100mL in mini bag      

                                       Plus container

Lot Number:                P337857

Expiration date:          31/07/2016

NDC :                            0338-0553-18     

Product code:              2B7721

Product Description:  Clinimix E 5/15 (5% w/Electrolyte in 15% Dextrose     

                                       w/Calcium)

Lot Number:                P333930

Expiration date:          31/05/2017

NDC :                             0338-1123-04         

        

NAFDAC implores importers and healthcare providers to exercise caution and discontinue the purchase, administration and use of these products.

NAFDAC implores all outlets with this product to immediately stop circulation and submit products to the nearest NAFDAC office for appropriate action.

Healthcare providers should report all adverse events to NAFDAC PRASCOR (20543-Toll free from all networks) or via This email address is being protected from spambots. You need JavaScript enabled to view it.

NAFDAC…..Safeguarding the health of the Nation!!!

The Agency has been notified of the Singaporean Health Science Authority (HSA) recall of two (2) batches of children’s’ Guaifenesin grape liquid (100mg/5ml) and three (3) batches of children’s’ Guaifenesin DM cherry liquid (100mg Guaifenesin and 5mg dextromethorphan HBr/5ml) contained in 4 oz. bottles with oral dosage cups in a box under multiple store brand product names. The recall was due to some packages containing oral dosing cups with incorrect dose markings. The products are indicated for helping loosen phlegm (mucus) and thin bronchial secretions, and in the case of the DM product to temporarily relieve: coughs due to minor throat irritations, the intensity of coughing, and the impulse to cough.

Possible risk associated with the affected batches

  • Poor metabolizers of dextromethorphan may experience an overdose by a factor of 3, if incorrect measuring levels are used. Therefore, children who are poor metabolizers of dextromethorphan and use the product regularly over a period of several days at the mistaken dose, may develop cumulative toxicity
  • Overdose of Guaifenesin DM may cause hyper excitability, rapid eye movements, changes in muscle reflexes, ataxia, dystonia, hallucinations, stupor, and coma. Other effects have included nausea, vomiting, tachycardia, irregular heartbeat, seizures, respiratory depression, and death in extreme cases.

Details of the affected lots are as follows:

GUAIFENESIN GRAPE LIQUID 4 OZ

Label                     Lot number                   Expiry
H.E.B                        5LK0592                     08/2017
CVS                        5MK0340                     08/2017

GUAIFENESIN DM CHERRY LIQUID 4 OZ

Label          Lot number                  Expiry
Sunmark         5LK0528, 5LK0630                03/2017
Rite-Aid         5LK0528, 5LK0630                03/2017
Topcare         5LK0528, 5LK0630, 5LK0779                03/2017
Kroger         5LK0528, 5LK0630                03/2017
GoodSense         5LK0528                03/2017
Dollar General         5LK0630                03/2017
Care One         5LK0630                03/2017
CVS         5LK0630                03/2017

NAFDAC implores importers and healthcare providers to exercise caution and discontinue the purchase, administration and use of these products.

NAFDAC implores all outlets with this product to immediately withdraw them from the market.

Healthcare providers should report all adverse events to NAFDAC PRASCOR (20543-Toll free from all networks) or via This email address is being protected from spambots. You need JavaScript enabled to view it.

NAFDAC…..Safeguarding the health of the Nation!!!

Inadequate opioid for the treatment of serious pain and lack of access to narcotic drugs for the management of similar conditions have remained a major health concern especially people suffering from these health conditions.

The Acting Director General of NAFDAC, Mrs. Yetunde Oni who expressed this concern at the presentation and dissemination of the 2015 Annual Report of the International Narcotics Control Board (INCB) at NAFDAC corporate headquarters in Abuja said the Federal Ministry of Health and NAFDAC with the support of INCB have made tremendous progress toward meeting the country’s requirements of opioids.

She noted that under the National Drug Control Master Plan, provisions have been made to decentralize the distribution of narcotic drugs by the establishment of zonal drug distribution centres in the six geo-political zones to enhance access to these drugs for licit purposes.

Speaking further, Mrs. Oni said the Agency is conscious of the persistent and emerging challenges regarding drug problem in Nigeria and is working assiduously with relevant stakeholders, National Authorities and international organizations to address this challenge.

Particularly, she noted that the National Drug Control master plan developed under the auspices of EU-Funded NGAV16 project implemented by UNODC has provided a robust framework for drug control and given the National Authorities a window for closer collaboration and co-ordination.

This collaboration according to her is what the Agency has adopted in monitoring of legitimate trade in precursors, using the Pre-Export Notification Online (PEN Online), an initiative of INCB.

Delivering a keynote address at the event, Chairman of National Drug Law Enforcement Agency (NDLEA), Col. Muhammad Abdallah (Rtd) said some cases of diversion of imported precursor chemicals have been detected by his agency leading to arrest of some culprits, stating that, the discovery and dismantling of 10 clandestine laboratories in Lagos and Anambra states by NDLEA between 2011-2015 attests to the illegal diversion of these products.

He regretted the upward trend in the use of Tramadol over the years which has led to significant seizures of the drug and arrest of suspects involved.

Reviewing the report, the Country Representative of United Nations Office on Drug and Crime UNODC, Ms. Cristina Albertin said the 2015 Annual Report focuses on the health and welfare of mankind: challenges and opportunities for international control of drugs.

NAFDAC……..Safeguarding the health of the Nation!

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