Recalls & Alerts Published by NAFDAC

Thursday, 01 December 2016 07:18

Recall of AVEA ventilator Care Fusion

The National Agency for Food and Drug Administration and Control has been notified of the recall of AVEA ventilator by Care Fusion. The recall was due to a faulty fuse on the ventilator s’ alarm board.

The AVEA ventilator system is a versatile critical care ventilator intended for continuous breathing support in neonatal, pediatrics, and adult patients with complex respiratory diseases.

Product details:

            Product name: AVEA ventilator

            Product manufacturer:  CAREFUSION

                                                22745 Savi Ranch Parkway

                                                Yorba Linda CA 92887

            Manufacturing Dates: November 13, 2015 to January 4, 2016

            Distribution Dates: December 16, 2015 to February 15, 2016

Recalled Product:

                        Product Description                                        Product Numbers

AVEA Standard with compressor ventilator- refurbished                  R17312-xx (xx= 0-14)

AVEA Comprehensive ventilator                                                    17310-xx (xx= 0-14)

AVEA Standard ventilator                                                             17311-xx (xx= 0-14)

AVEA standard with compressor ventilator                                     17312-xx (x= 0-14)

AVEA Comprehensive ventilator – refurbished                                R17310-xx (xx= 0-14)

AVEA Standard ventilator – refurbished                                         R17310- xx (xx=0-14)

AVEA Standard with compressor ventilator-refurbished                   R17312-xx (xx-0-14)

TCA Board                                                                                 16542A

GDE-1st generation                                                                     16222-001-99

GDE                                                                                           16650A

GDE-refurbished                                                                          R16650A

AVEA GDE/UIM upgrades kit                                                        12283-PMN

Possible risks

  • the ventilator may shut down unexpectedly which will lead to the patient not getting enough oxygen resulting to suffocation and possible death of the patient

Healthcare Providers’ action

  • Discontinue use of device
  • Report all serious adverse events or side effects related to the use of this device to NAFDAC PRASCOR (20543-TOLL FREE FROM ALL NETWORK) or via individual case safety report forms or via email: This email address is being protected from spambots. You need JavaScript enabled to view it. .

 

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

Tuesday, 22 November 2016 07:45

Recall Of Respontin Nebules In Dublin

The National Agency for Food and Drug Administration and Control has been informed that the Irish Health Product Regulatory Authority, Dublin announced the recall of four (4) batches of Respontin Nebules 250 microgram/1ml Respontin Nebules five hundred (500) microgram/2ml (Ipratropium Bromide) by GlaxoSmithKline over out of specification results for impurities .

Respontin Nebules is indicated for the treatment of reversible airway obstruction. It is used in a nebulizer, a machine that converts the liquid medicine inside the nebules into particles that can be inhaled.

The details of the recalled product are as follows:

i.   Batch Number: B76315Ba

Expiry date: 28/02/2017

Pack Size: 20x1ml

First distributed: 30th March, 2015

ii.   Batch Number: B85515J

Expiry date: 31/10/2017

Pack Size: 20x1ml

First distributed: 27th January, 2015

iii.  Batch Number: B76315BA

Expiry date: 28/02/2017

Pack Size: 4x5x2ml

First distributed: 29th May, 2015

iv.  Batch Number: B85515J

Expiry date: 31/10/2017

Pack Size: 4x5x2ml

First distributed: 18th December, 2015

Healthcare providers with stock of the products should immediately discontinue the administration or use of the products.

Healthcare professionals and consumers should report 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 National Agency for Food and Drug Administration and Control hereby informs the general public of the recall of some drugs manufactured by Ta Fong Pharmaceutical Company Limited, over quality concerns.

The affected products are;

  1. Urodine F.C. Tablets SGP-56569
  2. Dicokan Tablets (30mg) SGP-56102
  3. Toeefon Tablets (250mg) SGP-56387
  4. Shoren Suppositories (12mg) SGP-60943
  5. Molin Tablets (10mg) SGP-62483
  6. Famoster Film coated Tablets (20mg) SGP-62850
  7. Lincomycin solution for injection (300mg/ml) HK-61712
  8. Clindamycin Capsules (150mg) SGP-64191

The products are not registered by NAFDAC.

The importers and the general public are implored to avoid the importation, purchase or use of these products.

Any information on the distribution and sale of the product should be reported to the nearest NAFDAC office, 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!!!

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