Monday, 08 February 2016 13:33

Voluntary Recall Of Norepinephrine Bitartrate By Pharmedium

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The attention of the agency has been drawn to the voluntary recall of 29 lots of 4mg Norepinephrine Bitartrate (16mcg/mL) added to 0.9% Sodium Chloride in 250mL Viaflex Bag and 3 lots of 8mg Norepinephrine Bitartrate (32mcg/mL) added to 0.9% sodium chloride in 250mL Viaflex Bag by PharMEDium. Norepinephrine bitartrate injection functions as a peripheral vasoconstrictor (alpha-adrenergic action) and as an inotropic stimulator of the heart and dilator of coronary arteries (beta-adrenergic action). This product is an injectable drug used in blood pressure control in certain acute hypotensive states (e.g., pheochromocytomectomy, sympathectomy, poliomyelitis, spinal anesthesia, myocardial infarction, septicemia, blood transfusion, and drug reactions).

Reason for recall

Discoloration of the admixture indicating degradation and may reduce the potency of the product due to oxidation of Norepinephrine Bitartrate.

Possible risks

  • Possible delay of achieving desired therapeutic effect due to product impotency.

Recalled product details

Manufacturer:      PharMEDium

See affected lots below:

2K6134

Lot#

Expiration Date

15342084S

2/10/2016

15342191S

2/10/2016

15342223S

2/10/2016

15342224S

2/10/2016

15342225S

2/10/2016

15342226S

2/10/2016

15343025S

2/11/2016

15343026S

2/11/2016

15343129S

2/11/2016

15343131S

2/11/2016

15344157S

2/12/2016

15344160S

2/12/2016

15344209S

2/12/2016

15345036S

2/13/2016

15345104S

2/13/2016

15345106S

2/13/2016

15345142S

2/13/2016

15346015S

2/14/2016

15346016S

2/14/2016

15346017S

2/14/2016

15346018S

2/14/2016

15346019S

2/14/2016

15346020S

2/14/2016

15346022S

2/14/2016

15346023S

2/14/2016

15348152S

2/16/2016

15348197S

2/16/2016

15350046S

2/18/2016

15350154S

2/18/2016

 

2K6127

Lot#

Expiration Date

15342123S

2/10/2016

15349071S

2/10/2016

15351050S

2/10/2016

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Healthcare provider’s action

  • Healthcare providers should stop administration of affected products
  • Select and quarantine products affected lots or destroy product according to hospital destruction Policy.
  • Report adverse events or side effects related to the use of the product 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. and also encourage patients to do the same.

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

Read 9031 times Last modified on Wednesday, 18 May 2016 14:20

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