Recalls & Alerts Published by NAFDAC

Friday, 15 January 2016 00:00

Drug Safety Labeling Changes

The attention of the Agency has been drawn to the labeling changes of some drug products by the FDA. The changes are under the following sections: boxed warning, contraindications, warnings, precautions, adverse reactions or patient package insert/medication guide.

The table below provides a listing of drug product names and the safety labeling sections revised;

Drug Safety Labeling Changes Table

S/N

DRUG NAME

SECTIONS MODIFIED

BW

C

W

P

AR

PPI/MG

1

Atropine Sulfate Injection

 

X

       

2

BiaxinFilmtab (clarithromycin tablets, USP)

   

X

X

   

3

Biaxin Granules (clarithromycin for oral suspension, USP)

   

X

X

   

4

Biaxin XL Filmtab (clarithromycin extended-release tablets)

   

X

X

   

5

Eloxatin (oxaliplatin) Injection, for Intravenous Use

   

X

X

X

 

6

INOmax (nitric oxide) for Inhalation

   

X

X

   

7

Jadenu (deferasirox) Tablets

   

X

X

X

 

8

Letairis (ambrisentan) Tablets

   

X

X

X

 

9

Mirena (levonorgestrel-releasing intrauterine system)

   

X

X

X

 

10

Myfortic (mycophenolic acid) Delayed-release Tablets

   

X

X

X

 

11

Nicoderm CQ (nicotine transdermal system)

   

X

     

12

Opdivo (nivolumab) Injection

   

X

X

   

13

Ortho Evra (norelgestromin and ethinylestradiol transdermal patch)

   

X

X

   

14

Ortho-Novum Tablets (norethindrone/ethinylestradiol) Tablets and Modicon 28 Tablets (norethindrone/ethinylestradiol)

   

X

     

15

Picato (ingenolmebutate) Gel

 

X

X

X

X

 

16

Pradaxa (dabigatranetexilatemesylate) Capsules

   

X

X

   

17

Technivie (ombitasvir, paritaprevir, and ritonavir) Tablets

 

X

X

X

X

PCI

18

Viekira PAK (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets), Co-packaged for Oral Use

 

X

X

X

X

PCI

19

Yervoy (ipililumab) Injection

   

X

X

   

Key to Label Section Acronyms:

BW= Boxed Warning

C= Contraindications

W=Warnings

P=Precautions

AR= Adverse Reactions

PPI/MG= Patient Package Insert/Medication Guide

PCI = Patient Counselling Information

Healthcare Provider’s Action

NAFDAC… Safeguarding the health of the Nation!

The National Agency for Food and Drug Administration and Control hereby inform the general public that FDA and the New York Department of Health found potentially unsafe levels of mercury and lead in several Baidyanath brand ayurvedic dietary supplements manufactured by Shree Baidyanath Ayurved Bhawan in India which, if consumed, may cause health problems to consumers, particularly infants, small children, pregnant women, and those with underlying kidney disorders. Short-term exposure to mercury consumption may lead to renal or gastrointestinal issues, while long-term exposure may cause psychiatric and personality disturbances, ataxia (or loss of coordination), visual or hearing loss, and other neurological conditions particularly fetal neurological issues with pregnant patients. Lead exposure in children younger than 6 years may lead to nervous system damage potentially causing learning difficulties or delayed development and in pregnancy can cause nervous system damage to the fetus or cause miscarriage. Symptoms associated with lead poisoning include memory loss, unexplained hypertension, severe constipation, or extremity numbness.

The products can be obtained from retail outlets and via the internet. Butala Emporium Inc. one of the major retailer of the products has recalled the following Baidyanath brand ayurvedic supplements: Agnitundi Bati, Arogyavardhini Bati, Brahmi Bati, Chitrakadi Bati, Gaisantak Bati, Marichyadi Bati, Rajahpravartini Bati, Saptamrit Lauh, Sarivadi Bati, Shankh Bati.

NAFDAC implores the members of the public, importers and consumers to be pro-active by ensuring that these products are not purchased.

NAFDAC…..Safeguarding the health of the Nation

The attention of the agency has been drawn to nationwide voluntary recall of lots of Myocardial Protection System delivery sets by Quest Medical, Inc. The product(s) have been found to intermittently exhibit a seal failure during use, which potentially could result in patient blood loss. These products were manufactured from May 2015 to September 2015 and distributed from June 2015 to September 2015.

Loss of blood during surgery can result to anaemia which when severe causes shock leading to damage to organs such as kidney and brain, heart attacks, gangrenes of arms and legs and death of patient undergoing surgery and so Quest Medical Inc. Is asking doctors using the device to cease use of the device affected lot and return them to place of purchase for replacement.

Device Name

MPS Delivery Set w/arrest agent and additive cassettes, heat exchanger & 10 ft. delivery tubing

MPS Delivery Set with 6 ft. delivery tubing

MPS Low Volume Delivery Set

Device Model

5001102

5001102-AS

7001102

UDI

00634624501126

00634624521124

00634624701120

Affected Lots

0491795E04, 0492175E04, 0492185E06, 0492195E06, 0492615E06, 0492625E08 0492635E08, 0489905Y04, 0490245Y06, 0493075U02, 0493085U02, 0493435U04 0493675U04, 0493685U07, 0494465U07, 0494475U09, 0494855G01, 0495215U11 0495225U11, 0495505G02, 0495515G02, 0496535G08, 0496875G08, 0496885G08 0497245S02

0492205E03 0493695U04 0494485U07 0495525G02 0497265S02

0492765E07

Action required from doctors

Doctors should be aware of this and report blood losses related to the use of these products to NAFDAC PRASCOR system (send text to 20543 from all network providers) or via adverse event report forms or email: 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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