Recalls & Alerts Published by NAFDAC

Monday, 08 February 2016 13:48

Recall - Undeclared Drug Ingredients

The National Agency for Food and Drug Administration and Control hereby inform the general public of the voluntary recall of Smart Lipo (800, 900, 950 mg) capsules by SmartLipo365. Smart Lipo is marketed as a dietary supplement and is packaged in bottles of 30 capsules in 800mg, 900mg, and 950mg per capsule. According to FDA certain undeclared ingredients like sibutramine, desmethylsibutramine, and phenolphthalein were discovered in the recently conducted analysis which makes these products unapproved new drugs for which safety and efficacy have not been established. These products if taken concomitantly with other medication may interact in life-threatening manners.

Sibutramine an appetite suppressant is known to increase blood pressure and/or pulse rate in some patients and may pose higher risk effects for patients with heart related health problems. Phenolphthalein is an ingredient previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is not currently approved for marketing in the United States. Health risks associated with phenolphthalein could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use.

NAFDAC implores the members of the public, importers, healthcare providers and consumers to exercise caution in the purchase, administration and use of these products.

NAFDAC…..Safeguarding the health of the Nation!

This is to bring to your notice important safety information for Etest PIP/TAZO/CON-4 PTC 256 manufactured by BioMerieux. The device aids healthcare providers predict effectiveness of the antibiotic combination PIP/TAZO (Piperacillin/Tazobactam) in treating serious infections.

Reason for Recall

  • Test results from Etest PIP/TAZO/CON-4 PTC 256 products may indicate that antibiotic therapy using PIP/TAZO could prove effective in the slowing or stopping of susceptive bacterial growth while in practice; it might prove ineffective.

Possible Risks

  • As a result of the device’s error, there may be delayed treatment of infection as the sub-effective antibiotics may be administered for longer durations in order to eliminate the bacterial load.
  • Treatment failure, sepsis or even death could result from administration of an ineffective antibiotic for a serious infection.

Information on Product Details                                               

  • Manufacturer –BioMerieux
  • Product - Etest PIP/TAZO/CON-4 PTC 256
  • Affected Range - All with manufacturing dates between Dec 20, 2012 to Oct 23, 2015 and distribution dates between Jan 24, 2013 to Nov 9, 2015.

Healthcare Provider’s action

  • Healthcare providers should be aware of the recall, inform all laboratory personnel and discontinue the use of the recalled products.
  • 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 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!

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