Recalls & Alerts Published by NAFDAC

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!

This is to notify you of important safety information for ED-530XT Duodenoscopes manufactured by Fujifilm Medical Systems, U.S.A. Duodenoscopes are lighted flexible tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum). They are used for endoscopy – an invasive diagnostic medical procedure used to assess the interior surfaces of an organ by inserting a tube into the body. As a result of its sensitivity, the device is to be regularly cleaned and disinfected or sterilized by a multistep process known as reprocessing.

Fujifilm Medical Systems Inc. re-evaluated and validated the manual reprocessing instructions of the device to replace those provided in the original device labeling. Upon assessment by the FDA, investigations showed that the validated reprocessing instructions when adhered to properly demonstrated more consistent and reliable cleaning and a high level of disinfection of the ED-530XT duodenoscopes.

Although the validated reprocessing instructions  includes a more rigorous protocol for pre-cleaning compared to the manual process; they however enhance the safety margin of the device and show a high degree of assurance of disinfection.

Healthcare Provider’s Action

  • Healthcare Providers should be aware of the validated reprocessing instructions and ensure that all device operators are intimated on it and adopt the procedure.
  • While formal validation testing is being conducted on reprocessing instructions for Fujifilm’s 250 and 450 duodenoscope models, healthcare providers are encouraged to apply the reprocessing instructions for ED-530XT duodenoscope to reprocess the 250 and 450 duodenoscope models.
  • 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!

The Agency has been notified of the important safety information for “supposed” sterile products manufactured by Chen Shwezin Inc; doing business as Park Compounding Pharmacy in Westlake Village, Calif.

During a recently conducted inspection of Park Compounding Pharmacy’s facility by the FDA, investigators observed a poor sterile product practice which queries the ability of the company to assure the sterility of the “sterile” products they compounded.

On 29th September 2015, the FDA recommended that Park Compounding Pharmacy should recall all its unexpired “sterile” products and cease further sterile operations until adequate corrections have been made to the mode of operation and/or the company’s facility. The company has however not adhered to the recall instruction.

Till date, there has been no documentation of adverse events associated with the use of products formulated by Park Compounding Pharmacy.

Healthcare Provider’s Action

  • Healthcare Providers should quarantine any sterile drug product manufactured by Park Compounding Pharmacy and desist from further administration of such.
  • Patients who have received some of these products should be contacted and notified of the recall.
  • 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 e-mail : 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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