110% 85% 90% 85% (continued) PQ - Semantic Scholar€¦ · 81.1 One unit labeled as “AMOXICO(TM)- 500” by “Plethico Pharmaceuticals Limited,” batch number 06533. Preah Vihear

Supple

men

talTabl

e1

Analysisofsamplescollectedaspart

ofOperationsStorm

IandStorm

II

OperationStorm

1

Country/source

Medicine/m

gperunit

No.offailed

samples(90–110%

)/No.collected(%

failed)

%APIdetailsfor

failedsamples

Notesandpackaging

Seizure

location

(sample

ID)

Availability

ofauthentic

reference

sample

Classification

Antibiotics

Cambodia

Oralamoxicillin/250mg/cap

1/3

(33%

)87.2

Samples(1)thatfailedAPIcontent:

Oneunitlabeledas“AMOXIC

ILLIN

CAPSULESBP250mg”by“Glenmark,”

batchnumberAJ4498004.

Siem

Reap

+

PQ

<90%

Samples(2)thatpassedAPIcontent:

Oneunitlabeledas“AMOX

-MS250

Amoxillin250mg”by“MS,”

batchnumber87299.

Siem

Reap

üAuthentic

Oneunitlabeledas“RxHAGIM

OX,

Amoxicilin

250mgNhai”

by“CTCPDUOCHAU

GIA

NG.”

Batchnumbernotstated.

PreahVihear

+

90–110%

Cambodia


2/5

(40%

)89.6


Oneunitlabeledas“Amoxicillin

500mg,”

by“LaboratoiresEphac

Co.Ltd,”

batchnumber82024.

Siem

Reap

+

PQ

<90%

81.1


O(T

M)-

500”by“PlethicoPharm

aceuticals

Lim

ited,”

batchnumber06533.

PreahVihear

+

PQ

<85%


Twounitslabeledas“Amoxicillin

500mg”by“BAIL

LY-C

REAT,”

batchnumber132and125.

Siem

Reap(132);

Phnom

Penh(125).

üAuthentic

Oneunitlabeledas“AMOX-M

S500,Amoxicillin500mg”by“MS,”

batchnumber87110.

Phnom

Penh

üAuthentic

Oneunitlabeledas“Pulm

oxyl(R

)-500

AMOXIC

ILLIN

CAPSULESBP

500mg”by“Micro

Laboratories

Lim

ited,”

batchnumber“PXFB0327”

Siem

Reap

+

90–110%

Cambodia

Oralampicillin/500mg/cap

3/7

(43%

)−


45.8

Oneunitlabeledas“AMPIC

ILLIN

,Ampicillin500”by“ShijiazhuangOuyi

Pharm

aceuticalCo.,Ltd,”

batchnumber0529

Siem

Reap

+

PQ

<85%

89.5


ILLIN

CapsulesBP500mg”by“Glenmark,”

batchnumber“AJ4368019.”

Siem

Reap

+

PQ

<90%

84.0


O-500,

Ampicillin,GelulesB.P.500mg”by

“PlethicoPharm

aceuticalsLtd,”

batchno.6393

PreahVihear

+

PQ

<85%

(continued)

SUPPLEMENTALTABLE1

Continued

OperationStorm

1

Country/source

Medicine/m

gperunit

No.offailed

samples(90–110%

)/No.collected(%

failed)

%APIdetailsfor

failedsamples

Notesandpackaging

Seizure

location

(sample

ID)

Availability

ofauthentic

reference

sample

Classification

−Samples(4)thatpassedAPIcontent:

−Oneunitlabeledas“AMPIC

ILLIN

E500mg”by“Bailly-C

reat,”

batchnumber295.

Siem

Reap

+

90–110%


ILLIN

CAPSULESBP500mg,Dynacillin-500”

by“Micro

LaboratoriesLim

ited,”

batchnumberDYFB0039.

Siem

Reap

+90–110%


ILLIN

E500mg”by“LABORATOIR

ES

EPHACCo.,Ltd,”

batchnumber82013.

Siem

Reap

+

90–110%

−Oneunitlabeledas“AMPIM

ASTER,

AmpicillinCapsules500mg”by

“ShandongReyoungPharm

aceutical

Co.,Ltd,”

batchnumber080808.

PreahVihear

+

90–110%

Cambodia

Oralphen

oxymethylpen

icillin

(Pen

V)/~0.6g/tab

0/1

(0%

)–

Oneunitlabeledas“OspenÒ1000”

Unknown

+

90–110%

Phenoxymethylpenicillinaspotassium

salt

B.P

1,000,000IU

“(~0.6

g)”

by

“SANDOZ,”

batchnumber152890.

Cambodia

Oralphenoxymethylpenicillin

(PenV)/mg/tabnotstated.

Assumedto

be250mg/tab

0/1

(0%

)−

Loose

tabletspackedin

plasticbagwithout

identity

labeling.

Phnom

Penh

+

90–110%

Cambodia

Oralphenoxymethylpenicillin

(PenV)/250mg/tab

0/1

(0%

)−

Oneunitwithpaperslip

stating

“Penicillin-V

Tablet,PenicillinV

Potassium

equivalentto

PenicillinV

250mg.(400,000iu),60tablets”by

“T.ManPharm

aLtd,Part.,”

batchnumber6025104.

PreahVihear

+

90–110%

Cambodia

Oraltetracycline/250mg/cap

0/3

(0%

)–

Oneunitwithpaperslip

stating

“TETRAMAN

CAPSULE,

TetracyclineHCl250mg”by

“T.M

anPharm

aLtd,Part.,”

batchnumber7455106.

PreahVihear

+

90–100%

Oneunitlabeledas“TETRA-250,


“Labo.EPHAC,”

batchnumber81066.

PreahVihear

+

90–110%


TetracyclineHydrochloride250mg”

by“EPHACCo.,Ltd,”

batchnumber81098.

PreahVihear

+

90–110%

Antimalarials

Cambodia

Oralartesunate/50mg/tab

1/5

(20%

)83.4


Oneunitlabeledas“Artesunate

50mg”by“BinhdinhPharm

a,”

batchnumber02706.

Phnom

Penh

+

PQ

<85%

(continued)

SUPPLEMENTALTABLE1

Continued

OperationStorm

1

Country/source

Medicine/m

gperunit

No.offailed

samples(90–110%

)/No.collected(%

failed)

%APIdetailsfor

failedsamples

Notesandpackaging

Seizure

location

(sample

ID)

Availability

ofauthentic

reference

sample

Classification


Twounitslabeledas“

,Artesunate

Tablets,50mg

+12

,50

mg

+12tablets,

”by“G

uilin

Pharmaceu

ticalCo.,Ltd

China,”

batch

number

071201

OlympicMarket,

Phnom

Penh

üAuthentic

Fiveunitslabeledas“Artesunate

50mg”by“BinhdinhPharm

a,”

three

withbatchnumber2307,onewith

batchnumber0108andonewith

batchnumber6508.

Rattanak

iri(2307);

OlympicMarket,

Phnom

Pen

h(0108);

Siem

Reap(6508).

+

90–100%

Cambodia

Oralchloroquine/250mg/tab

0/3

(0%

)–

Oneunitconsistedofloose

tablespacked

inplasticbagindicatedasmanufactured

by“Adhon,”

batchnumber9305by

thesubmitter.

PreahVihear

+

90–110%


tablespacked

inplasticbagindicatedas“Chloroquine

250mg,”

batchnumber216AM

bythe

submitter.Manufacturernotstated.

PreahVihear

+

90–110%


tablespacked

inplasticbagindicatedas“Chloroquine”

by“ACDHO”bythesubmitter.Batch

numbernotstated.

Siem

Reap

+

90–110%

Cambodia

Oraldihydroartemisinin

(40mg)-piperaquine

phosphate

(320mg)

co-form

ulatedtabs

0/1

(0%

)−

Oneunitlabeledas“Artekin,Compound

Dihydroartemisinin”by“Holleykin

Pharm


batch

number011206.

OlympicMarket,

Phnom

Penh

+s90–110%

Cambodia

Oralmefloquine(250mg)+

artesunate

(50mg)

co-blisteredtabs

0/3

(0%

)−

Threesampleslabeledas“A

+M2,”

“A

+M3”and“A

+M4”withbatch

numbers

0818,00718and303117,

respectively.Manufacturernotstated.

Kandal

+

90–110%

Cambodia


artesunate

(200mg)

co-blisteredtabs

1/2

(50%

)Artesunate

85.0,

Mefloquine103.1

Sample

(1)thatfailedAPIcontent:

Onelabeledas“Malarine(R

),3DayMalariaTreatm

ent,

COMPOSIT

ION:Mefloquine(250

milligramsbase)4tablets,Artesunate

(200mgbase)3tablets,”

“product

importedandrepackagedin

Cambodia,”

batchnumber337116.

Phnom

Penh

üSubstandard

<90%

Sample

(1)thatpassedAPIcontent:

Onelabeledas“Malarine”(T

haiPrinting),

batchnumber02018.Manufacturer

notstated.

DumexMarket,

Phnom

Penh

üAuthentic

Indonesia

imartemether/80mg/vial

1/1

(100%

)88.5

Oneunitlabeledas“Artemetherfor

injection”by“KunmingPharm

aceutical

Corp.,”batchnumber20050630.

Jayapura,Papua

üSubstandard

<90%

(continued)

SUPPLEMENTALTABLE1

Continued

OperationStorm

1

Country/source

Medicine/m

gperunit

No.offailed

samples(90–110%

)/No.collected(%

failed)

%APIdetailsfor

failedsamples

Notesandpackaging

Seizure

location

(sample

ID)

Availability

ofauthentic

reference

sample

Classification

Indonesia

iv/im

artesunate/60mg/vial

0/2

(0%

)−

Twosampleslabeledas“Artesunate

forinjection”by“Guilin

Pharm

aceutical

Co.,Ltd,China,”

batch

numberZA20060905andZA071102.

Ambon,Maluku

(ZA20060905);

Jayapura,Papua

(ZA071102)

üAuthentic

Indonesia

Oralartesunate

(50mg)+

amodiaquine(153mg)

co-blisteredtabs

1/2

(50%

)Artesunate

79.8,

Amodiaquine98.2

Sample


Oneunitlabeledas“Artesdiaquine(R

)tablets,Artesunate

50mg

+12Tabs+

Amodiaquine200mg

+12Tabs”

by“BeijingW

anhuiDouble

Crane

Pharm

aceuticalCo.,Ltd,Beijing,China,”

batchnumber030406.

Jayapura,Papua

+PQ

<85%

Sample


Oneunitlabeledas“Artesdiaquine(R

)tablets,Artesunate

50mg

+12Tabs+

Amodiaquine200mg

+12Tabs”

by

“BeijingW

anhuiDouble

Crane

Pharm

aceuticalCo.,Ltd,Beijing,China,”

batchnumber091006.

Ambon,Nusa

Tenggara

Tim

ur

+

90–110%

Indonesia

Oralartesunate

(50mg)+

amodiaquine(150mg)

co-blisteredtabs

0/2

(0%

)−

Twosampleslabeledas“ARSUAMOON,

Artesunate

Tablet+Amodiaquine

HydrochlorideTablets”by“Guilin

Pharm

aceuticalCo.,Ltd,China,”

batchnumbers

L0071110andL0071105.

Jayapura,Papua

(L0071110);

Ambon,Nusa

Tenggara

Tim

ur

(L0071105).

+

90–110%

LaoPDR


4/9

(44%

)−


0,0

Twounitslabeledas“

,ArtesunateTab

lets,50mg

+12

,50mg

+

12tablets,

”(“Guilin

Pharm

aceuticalCo.,Ltd,China”),

batchnumber060207.Theblisterpacks

did

notbearanyhologramsandhad

Type1counterfeitpackaging.

Southern

Laos

üCounterfeit

86.2

Oneunitlabeledas“Artesunat50mg”

by“Mekophar,”batchnumber06001AN.

üSubstandard

<90%

143.5



üSubstandard

>115%

89.6


50mg”

by“Mediplantex,”

batchnumber061106

üSubstandard

<90%


−Oneunitlabeledas“Artesunat50mg”

by“Nam

Ha(N

aphaco),”batch

number07102.

üAuthentic

−Twosampleslabeledas“Artesunat50mg”

by“Mekophar,”batchnumber07006FN

and06004AN.

üAuthentic

−Oneunitlabeledas“Artesunate

50mg”

by“Mediplantex,”

batchnumber39007.

+

90–110%

−Oneunitlabeledas“Artesunat50mg”

by“X.N

.D.P.T.U

.I,”

batchnumber010807.

x90–110%

(continued)

SUPPLEMENTALTABLE1

Continued

OperationStorm

1

Country/source

Medicine/m

gperunit

No.offailed

samples(90–110%

)/No.collected(%

failed)

%APIdetailsfor

failedsamples

Notesandpackaging

Seizure

location

(sample

ID)

Availability

ofauthentic

reference

sample

Classification

Myanmar

Oralartemether/50mg/tab

0/4

(0%

)–

Threesampleslabeledas“Antimalarial,

Artem,ArtemetherTabletsART50mg”

by“KunmingPharm

aceuticalCorp.,

China,”

batchnumbers

06116801,070DF2

and07DF1.

Bahan,Yangoon

(06116801);

+

90–110%

Myawaddy

(070DF2,

07DF1).

Oneunitlabeledas“AA-A

rtemether50mg

AntimalarialAgent,ART,50mg”by

“AA

MedicalProductsLtd,”

batch

number070911.

Kawthaung

+

90–110%

Myanmar


1/4

(25%

)79.9


Oneunitlabeledas“AA-A

rtesunat50mg,

12tablets,AntimalarialAgent”

by

“AA

MedicalProductsLtd,”

batch

number070901.

Bahan,Yangoon

+

PQ

<85%


Twosampleslabeledas“Specific

antimalarial,ARTESUNATETABLETS,

,”by

“Guilin

Pharm


batch

numbers

070908and080206.Some

differencesfrom

authenticsample

but

concludedto

beprobably

authenticsample.

Myawaddy

üAuthentic

Oneunitlabeledas“ORALROUTE

ARTESUNAT”by“Central

Pharm

aceuticalFactory,”

batch

number010607.

Tachileik

+

90–110%

Myanmar

Oralmefloquine/250mg/tab

0/1

(0%

)−

Oneunitlabeledas“Mevax,Mefloquine

Tablets250mg”by“Ajanta

pharm

alimited,”

batchnumberM0037D.

Tachileik

+

90–110%

Myanmar


artesunate

(200mg)

co-blisteredtabs

1/1

(100%

)Artesunate

91.9,

Mefloquine88.1

Oneunitlabeledas“Arfloquin”by

“Mekophar,”batchnumber07003FX.

Kawthaung

+

Mefloquine

PQ

<90%

Thailand

ivartesunate/60mg/vial

1/1

(100%

)110.9


for

injection”by“Guilin

Pharm

aceutical

Co.,Ltd,Guangxi,China,”

batch

numberZA080202.(Importedby

AtlanticPharm

aceuticalCo.,Ltd,

Bangkok,Thailand).

Unknown

+

PQ

>110%

Thailand


0/1

(0%

)97.2%

Oneunitlabeled

as“

,Artesunate

Tab

lets”by“

”(“Guilin

Pharmaceu

ticalCo.,Ltd,China”),

batch

number

080207.Somedifferences

from

authen

ticsample

butconcluded

tobeprobab

lyau

then

ticsample.

Unknown

üAuthentic

Vietnam

Oralartesunate/50mgtab

1/5

(20%

)83.7


Onelabeledas“Artesunat50mg”by

“MekopharChemicalPharm

aceutical

Hanoicity

üSubstandard

<85%

(continued)

SUPPLEMENTALTABLE1

Continued

OperationStorm

1

Country/source

Medicine/m

gperunit

No.offailed

samples(90–110%

)/No.collected(%

failed)

%APIdetailsfor

failedsamples

Notesandpackaging

Seizure

location

(sample

ID)

Availability

ofauthentic

reference

sample

Classification

Joint-Stock

Co.HCM,Vietnam,”

batchnumber07001FN.



by“CTCPDPNam

Ha(N

aphaco),”

batchnumber07101.

VinhLocDistrict,

ThanhHoa

Province

üAuthentic

Twosampleslabeledas“Artesunat50mg”

by“CTCPHDPMekophar”

withbatch

number06001AN

and06004AN.

HaGiangTown,

HaGiang

Province

(06001AN);

Unknown

(06004AN)

üAuthentic


by“MekopharChemicalPharm

aceutical

Joint-Stock

Co.HCM,Vietnam”with

batchnumber07004FN.

ThanhHoaTown,

ThanhHoa

Province

üAuthentic

Vietnam

Oralchloroquine/250mg/tab

0/3

(0%

)–

Oneunitconsistedloose

tabletspackedin

plasticbagwithpaperlabelstating

“Chloroquine250mg”by“Mekophar

ChemicalPharm

aceuticalJoit-Stock

Co,”

lotnumber“06001AN”andexpiry

date

“06/2010”

HaGiangTown,

HaGiang

Province

+

90–110%

Twounitslabeledas“CLOROQUIN

phosphat250mg”by“Namha

Pharm

aceuticalJoint-Stock

Co,Vietnam,”

batchnumber06102.

HaGiangTown,

HaGiang

District

üAuthentic

Oneunitlabeledas“CLOROQUIN

PHOSPHAT250mg”by“Mekophar,

HCM

City,”

batchnumber07001CN.

HaNoicity

üAuthentic

Vietnam

Oralquinine/250mg/tab

0/1

(0%

)−

Consistedloose

tabletspackedin

plasticbag

withpaperlabelstating“Quinine250mg”

by“MekopharChemicalPharm

aceutical

Joit-Stock

Co,”

batchnumber“0030905”

HaGiangTown,

HaGiang

Province

+

90–110%

Vietnam

Oralsulfadoxine(500mg)+

pyrimethamine(25mg)

co-form

ulatedtabs

0/3

(0%

)−

Threesampleslabeledas“CTCPHoa-D

uoc

pham,Mekophar,MEKOFAN”by

“Mekophar,”batchnumbers

0010405,

0021205,and06001AN.

VinhLocDistrict,

ThanhHoa

Province

+

90–110%

OperationStorm

II

Country/source

Medicine/m

gperunit

No.offailed

samples(90–110%

)/no.collected(%

failed)

Chemicalassay

detailsforfailed

samples(actual%

API)

Notesandpackaging

Seizure

location

Authenticpackaging

anddosage

form

savailable

Antibiotics

Cambodia


1/1

(100%

)85.3

Oneunitlabeledas“Amoxicillin250mg”

by“LABORATOIR

ESEPHAC

Co.,Ltd,”

batchnumber82030.

Unknown

+

PQ

<90%

Cambodia


1/7

(14%

)48.5

Sample



ILLIN

500mg”by“ShijiazhuangOuyi

Unknown

+

PQ

<85%

(continued)

Supple

men

talTabl

e1

Continued

OperationStorm

II

Country/source

Medicine/m

gperunit

No.offailed

samples(90–110%

)/no.collected(%

failed)

Chemicalassay

detailsforfailed

samples(actual%

API)

Notesandpackaging

Seizure

location

Authenticpackaging

anddosage

form

savailable

Pharm


batch

number0329.



ILLIN

E500mg”by“LaboratoiresB.F.,”

batchnumber83.

Pailin

+90–110%


ILLIN

CAPSULESBP500mg”by“E.K

.HCo.,Ltd,”

batchnumber081110.

Unknown

+

90–110%

Oneunitlabeledas“Amoxicillin500mg”


Unknown

+

90–110%

Oneunitlabeledas“AMOXMASTER,

AmoxicillinCapsules500mg”by

“SHANDONG

ReyoungPharm

aceuticaL

Co.,Ltd,”

batchnumber080807

Unknown

+

90–110%


ILLIN

E500mg”by“LaboratoriesP.P.M

.,”

batchnumber1027

Unknown

+

90–110%


ILLIN

CAPSULESBP500mg”by“Glenmark,”

batchnumberAE4377019.

Unknown

+

90–110%

Cambodia


1/1

(100%

)70.4


ILLIN

E250mg”

by“LaboratoiresEphacCo.Ltd,”

batchnumber82009.

Unknown

+

PQ

<85%

Cambodia


5/7

(71%

)−


42.3


ILLIN

500mg”

by“ShijiazhuangOuyiPharm

aceuticaL

Co.,Ltd”withbatchnumber0529.

Unknown

+

PQ

<85%

74.8


ILLIN

CapsulesBP500mg”by“Glenmark”

withbatchnumberAJ4368028.

Unknown

+

PQ

<85%

71.1


ILLIN

CAPSULESB.P.500mg”by“Flamingo

Pharm

aceuticalsLtd,”

batchnumber413.

StungTreng

+

PQ

<85%

80.6


ILLIN

CAPSULESB.P.500mg”by“E.K

.HCo.,Ltd,”

batchnumber081109M.

Unknown

+

PQ

<85%

15.3

(contains

amoxicillin

66.6

mg/cap)

Oneunitlabeledas“AMPIM

EX-500,

AmpicillinCapsulesB.P.500mg,”

by

“FuLiPharm

aceutical,China.”

Batch

numbernotstated.

Battambang

+

Counterfeit


−Oneunitlabeledas“AMPIM

ASTER,

AmpicillinCapsules500mg”by

“ShandongReyoungPharm

aceutical

Co.,Ltd,”

batchnumber080808.

Battambang

+

90–110%

(continued)

SUPPLEMENTALTABLE1

Continued

OperationStorm

II

Country/source

Medicine/m

gperunit

No.offailed

samples(90–110%

)/no.collected(%

failed)

Chemicalassay

detailsforfailed

samples(actual%

API)

Notesandpackaging

Seizure

location

Authenticpackaging

anddosage

form

savailable

−Oneunitlabeledas“AMPI-MS500,

Ampicillin500mg”by“MedicalSupply

Pharm

aceuticalEnterprise

(MS),”batch

numberlT97095.

KohKong

Province

+

90–110%

Cambodia

Oralchloramphenicol/

250mg/cap

0/1

(0%

)−

Oneunitlabeledas

“CHLORAMPHENIC

OL”by“Hovid,”

batchnumberAH10598.

Unknown

+90–110%

Cambodia

Oralciprofloxacin/500mg/tab

0/2

(0%

)–

Oneunitlabeledas“CIPROXIN

-500,

CiprofloxacinTabletsUSP500mg.”

by

“UmedicaLaboratoriesPvtLtd,”

batch

numberZB801.

KampongCham

+

90–110%

Oneunitlabeledas“ECOFLOX-500,

CIPROFLOXACIN

TABLETSBP”by

“MedleyPharm

aceuticalsLtd,”

batch

numberD80244.

Unknown

+

90–110%

Cambodia

Oralcloxacillin/500mg/cap

1/1

(100%

)55.1

Oneunitlabeledas“CLOXA-M

S500”by

“MedicalSupply

Pharm

aceutical

Enterprise

(MS)”

withbatchnumber97014.

KohKong

Province

+

PQ

<85%

Cambodia

Oralmetronzidazole/250mg/tab

0/1

(0%

)−

Oneunitlabeledas“Metronidazole

TabletsB.P.250mg”by“Lyka

LaboratoriesLim

ited,”

batch

numberTL-137E.

KampongCham

+

90–110%

Cambodia

Oralphen

oxymethylpen

icillin

(Pen

V)/400,000IU

/tab

0/1

(0%

)–

Oneunitlabeledas“PENIC

ILLIN

VMingProv.

PsarPahi

+

90–110%

PENIC

ILLIN

VPOTASSIU

Mequi.

toPENIC

ILLIN

V400,000units”

by

“T.M

anPharm

aLtd,Part.”

withbatch

numberL/C6015102.

Cambodia

Oralphen

oxymethylpen

icillin

(Pen

V)/500,000IU

/tab

1/1

(100%

)82.5

Oneunitlabeledas“SQUASH

-PHENOXYMETHYLPENIC

ILLIN

500,000IU

”by“CheaChamnan

LaboratoireCo.,Ltd,”

batch

number080511.

Unknown

+

PQ

<85%

Cambodia

Oraltetracycline/250mg/tab

orcap

2/7

(29%

)−


81.7

Oneunitlabeledas“BIO

MAN,Sugar

coatedtablet,TetracyclineHCl250mg”

by“T.ManPharm

aLtd,Part.”

Batch

numbernotstated.

Unknown

+

PQ

<85%

87.4

Oneunitlabeledas“

,AQ,Masa

Laboratory,CONFIT

,Tetracycline

HydrochlorideCapsule

250mg.”

by

“Masa

Laboratory,”

batchnumber610245.

Unknown

+

PQ

<90%


−Twosampleslabeledas“Tetraman,

TetracyclineHydrochlorideCapsules

250mg,

”by“T.M

an

Pharm

aLtd,Part,”

batchnumber

L/C7455106andL/C7455108.

Unknown

(L/C7455106);

KampongCham

(L/C7455108)

+

90–110%

−Unknown

+

90–110%

(continued)

SUPPLEMENTALTABLE1

Continued

OperationStorm

II

Country/source

Medicine/m

gperunit

No.offailed

samples(90–110%

)/no.collected(%

failed)

Chemicalassay

detailsforfailed

samples(actual%

API)

Notesandpackaging

Seizure

location

Authenticpackaging

anddosage

form

savailable



“Labo.EPHAC,”

batchnumber81099.

−Oneunitlabeledas“

Vescomycin

TetracyclineHydrochloride250mg”by

“VESCO,”

batchnumber151013.

Unknown

+

90–110%

−Oneunitlabeledas“

,C.M

.P,Chea

ChamnanLaboratoire,TETRA

C.M

.P,

TetracyclineHydrochloride250mg.

Capsule”by“CheaChamnanLaboratoire

Co.,Ltd,”

batchnumber081009.

Unknown

+

90–110%

Cambodia


1/3

(33%

)88.5

Sample


Oneunitlabeledas“TETRACYCLIN

E500mg”by“LABO.EPHAC,”

batch

number91010.

KohKong

Province

+

PQ

<90%


Oneunitlabeledas“TETRACYCLIN

E500mg”by“Labo.Ephac,”batch

number81136.

Phnom

Penh

+

90–110%

Oneunitlabeledas“TETRA-M

S500

Tetracycline500mg”by“MS,”

batch

number80352.

Phnom

Penh

+

90–110%

Cambodia

Oraltetracycline/m

g/cap

notstated.Assumedto

be250mg/cap

1/1

(100%

)85.9%

(214.81mg/cap)


capsulespacked

inplasticbagwithoutidentity

labeling.

Capsuleswere

printedwith“MS”logo.

Batchnumbernotstated.

Unknown

+

PQ

<90%

LaoPDR

Oralsulfamethoxazole

(400mg)-trim

ethoprim

(80mg)co-form

ulated

tab#

4/4

(100%

)Sulfamethoxazole

(124,123,81,83,82),

(112,80,81),

(109,81,82,82),

(114,117,80,83,82),

Trimethoprim

(84,82,96,98,96),

(66,76,76),

(65,87,92,97)and

(69,67,84,87,86)


Oneunitas“Srim-side”by“KPN

Pharm

aFactory,”

Lot904002

VientianeCapital

+

PQ

<85%

>115%

Oneunitlabeledas“Sulfatrim

,”Lot0811035

+

PQ

<85%

>115%

Twosampleslabeledas“Vactrim”by

“Codupha-LaoPharm

aFactory,”

Lot916302and816303

+

PQ

<85%

>115%

LaoPDR


5/6

(83%

)82.2,82.6,84.1,

75.7

and86.8


Fivelabeledas“CODUPHA-LAO,

AMOXYCIL

LIN

,Amoxycilline500mg”

by“Codupha.”

FourfailedAPI%

85–115%

-onewithbatchnumber800252,

threewithbatchnumber800251andone

failedAPI%

90–110%

withbatch

number800234.

VientianeCapital

+

PQ

<85%

(continued)

SUPPLEMENTALTABLE1

Continued

OperationStorm

II

Country/source

Medicine/m

gperunit

No.offailed

samples(90–110%

)/no.collected(%

failed)

Chemicalassay

detailsforfailed

samples(actual%

API)

Notesandpackaging

Seizure

location

Authenticpackaging

anddosage

form

savailable


Onelabeledas“AmoxyM.H

.,Amoxicillin

(astrihydrate)500mg”by“M

and

HManufacturingCo.,Ltd”withbatch

number23CZ.

+

90–110%

LaoPDR

Oralampicillin/250mg/tab

1/1

(100%

)67.1

Loose

tabletspackedin

ziplock

bagswith

paperlabelstating“Ampicilline.”

Manufacturerandbatchnumberwere

notstated.

VientianeCapital

+PQ

<85%

LaoPDR


4/4

(100%

)79.0,67.7

82.9,

79.1,83.3

61.6

Twosampleslabeledas“CODUPHA-LAO,

AMPIC

ILLIN

,Ampicillin500mg”by

“Codupha”withbatchnumber800961

and800945.

VientianeCapital

+

PQ

<85%

Threeunitslabeledas“AMPIC

ILLIN

500,

AmpicillinTrihydrate

500mg”by

“P.D

.C.,”batchnumber012.

+

PQ

<85%


ILLIN

ECAPSULES”by“Zhangfeng

Pharm

aceuticalFactory,Longchuan,

Yunnan,China,”

batchnumber081101.

+

PQ

<85%

LaoPDR

Oralciprofloxacin/500mg/tab

1/4

(25%

)79.0

Sample


Oneunitlabeledas“Ciprocin500,”

batchnumber021007.Manufacturer

wasnotstated.

VientianeCapital

+

PQ

<85%


Oneunitlabeledas“Ciprofloxacin,

CiprofloxacinHCl500mg,”

batch

number28241207.Manufacturer

wasnotstated.

VientianeCapital

+

90–110%

Oneunitlabeledas“CIPROFLOXACIN

TabletsU.S.P.500mg”by“Brawn

LaboratoriesLtd,”

batch

numberBTG18017.

+

90–110%

Oneunitlabeledas“CIPROFLOXACIN

500mg”by“Thephaco,”

batch

number050908.

+

90–110%

LaoPDR


1/1

(100%

)89.6

Oneunitlabeledas“HEROLMYCIN

,250mg,Capsule”by“KPN

Pharm

aFactory,”

batchnumber801007.

VientianeCapital

+

PQ

<90%

LaoPDR

Oraltetracycline/250mg/tab

1/1

(100%

)131.3


tabletspackedin

plasticbaglabeledas“Leomycine

Tab250mg,072011.”

Manufacturerand

batchnumbernotstated.

VientianeCapital

+

PQ

>115%

Thailand

Oraldoxycycline/100mg/tab

0/1

(0%

)–

Oneunitlabeledas“DoxycyclineHyclate

Tablets,”

USP

Suvannabumi

Term

inal

Airport,

Bangkok

+

90–110%

100mgby“W

est-w

ard

Pharm

aceutical

Corp.,”batchnumber66112A.

(continued)

SUPPLEMENTALTABLE1

Continued

OperationStorm

II

Country/source

Medicine/m

gperunit

No.offailed

samples(90–110%

)/no.collected(%

failed)

Chemicalassay

detailsforfailed

samples(actual%

API)

Notesandpackaging

Seizure

location

Authenticpackaging

anddosage

form

savailable

Thailand

Oralphen

oxymethylpen

icillin

(Pen

V)/250mg/tab

0/1

(0%

)−


tabletspackedin

plasticbagwithoutidentity

labeling.

Indicatedas“Metro-V

250”withbatch

number0104022bythesubmitter.

Manufacturerwasnotstated.

MaesodDistrict,

Tak

+

90–110%

Thailand

Oralphen

oxymethylpen

icillin

(Pen

V)/400,000IU

/tab

0/2

(0%

)–


tabletspackedin

plasticbaglabeledas“PenV.400,000.”

Indicatedasmanufacturedby“Unison

LaboratoriesCo.,Ltd”withbatch

number“8PH30”bythesubmitter.

MuangDistrict,

Ranong

+

90–110%


ILLIN

VPOTASSIU

M400,000I.U.(250mg)”

by“UnisonLaboratoriesCo.,Ltd,”

batchnumber8PQ161.

+

90–110%

Thailand

Oralphen

oxymethylpen

icillin

(Pen

V)/500,000IU

tab

0/1

(0%

)−


ILLIN

TABLETS”by“A.N

.B.Laboratories

Co.,Ltd,”

batchnumber514634.

MuangDistrict,

Ranong

+

90–110%

Thailand

Oralphen

oxymethylpen

icillin

(Pen

V)/800,000IU

tab

0/2

(0%

)−

Twosampleslabeledas“PENIC

ILLIN

VPOTASSIU

M800,000I.U.”

by“Unison

Una”(“UnisonLaboratoriesCo.,Ltd”),

batchnumberL8PR01andL8PR03.

MaesodDistrict,

Tak(L

8PR01);

MuangDistrict,

Ranong

(L8PR03)

+

90–110%

Thailand

Oralphen

oxymethylpen

icillin

(Pen

V)/mg/tabnotstated

.Assumed

tobe250mg/tab

0/1

(0%

)−


tabletspacked

inplasticbagwithoutidentity

labeling.

Indicatedas“PenicillinV

potassium”

bythesubmitter.Manufacturerandbatch

numbernotstated.

MaesodDistrict,

Tak

+

90–110%

Thailand


1/3

(33%

)86.6

Sample



capsulesin


labeling.

Indicatedas“Tetracycline250mg”with

batchnumber5112051bythesubmitter.

Manufacturerwasnotstated.

MaesodDistrict,

Tak

+

PQ

<90%


Oneunitlabeledas“Tetra.250mg.”

Indicatedasmanufacturedby

“Pharm

asantLaboratoriesCo.,Ltd”

withbatchnumberL21015by

thesubmitter.

MuangDistrict,

Ranong

+

90–110%


capsulesin


labeling.

Indicatedasmanufacturedby“SevenStar

Co.,Ltd”withbatchnumber0824by

thesubmitter.

MuangDistrict,

Ranong

+

90–110%

Thailand


1/1

(100%

)87.3


capsulesin


labeling.

Indicatedas“Nidacycline500mg”with

MaesodDistrict,

Tak

+

PQ

<90%

(continued)

SUPPLEMENTALTABLE1

Continued

OperationStorm

II

Country/source

Medicine/m

gperunit

No.offailed

samples(90–110%

)/no.collected(%

failed)

Chemicalassay

detailsforfailed

samples(actual%

API)

Notesandpackaging

Seizure

location

Authenticpackaging

anddosage

form

savailable

batchnumber2581052bythesubmitter.

Manufacturernotstated.

Thailand

Oraltetracycline/m

g/cap

notstated.Assumedto

be250mg/cap

0/4

(0%

)–


capsulesin


labeling.

Indicatedas“NLMycin”withbatch



MaesodDistrict,

Tak

+

90–110%


capsulesin


labeling.

Indicatedas“AD

Mycine”withbatch

numberC4834bythesubmitter.


MaesodDistrict,

Tak

+

90–110%


capsulesin


labeling.

Indicatedasmanufacturedby“Asian

UnionLaboratoriesCo.,Ltd”withbatch


MuangDistrict,

Ranong

+

90–110%


capsulesin


labeling.

Indicatedas“Vescomycin”by“Vesco

Pharm

aCo.,Ltd,”

batchnumber15018

bythesubmitter.

Unknown

x90–110%

Antimalarials

Cambodia

Oralchloroquine/m

g/tab

notstated.Assumedto

be250mg/tab#

1/4

(25%

)(106,113,111,113),

(108,117,107,114),

(113,116,112,112),

110,147,119,111),

(108,122,121,114),

(110,122,116,118),

(109,118,119,115),

(108,114,112,115),

(110,115,115,118),

(102,113,115,117),

(105,114,120,112),

(103,115,116,117)

Sample


Unknown

Tenunitsof18–24tabletsin

plasticbags

w/o

identity

labeling,tabletswith

mosquitoim

ageembossedfailed

API%

85–115%

andtw

ounitsfailed

API%

90–110%

+

PQ

>115%

Sample


Threesamplesof18–23tabletsin

plastic

bagsw/o

identity

labeling,tabletswith

mosquitoim

ageembossed.

+

90–110%

Cambodia

Oralartesunate/50mg/tab#

2/5

(40%

)−


(88,82,88,107),

(84,82,90,89)

Twounitslabeledas“Manufactured

byBinhdinhPharm

a”andDistributed

by“Canapharm

2000Inc.,Edmonton,

Canada,”

LotNo2307.

Unknown

+

PQ

<85%

(128,119,104,103)

Oneunitlabeledas“Arquine”“Medical

Supply

Pharm

aceuticalEnterprise”

Phnom

Penh,Cambodia,Lot

number80036.

+

PQ

>115%


−Fiveunitslabeledas“Manufacturedby

BinhdinhPharm

a”andDistributedby

+

90–110%

(continued)

SUPPLEMENTALTABLE1

Continued

OperationStorm

II

Country/source

Medicine/m

gperunit

No.offailed

samples(90–110%

)/no.collected(%

failed)

Chemicalassay

detailsforfailed

samples(actual%

API)

Notesandpackaging

Seizure

location

Authenticpackaging

anddosage

form

savailable

“Canapharm

2000Inc,Edmonton,Canada,”

LotNo2908.

−Twosamples(7

units)

labeledas

“Arquine”“MedicalSupply

Pharm

aceuticalEnterprise”Phnom

Penh,

Cambodia,Lotnumbers

80998and80036.

+90–110%

Cambodia

OralDHA

(40mg)-piperaquine

(320mg)co-form

ulatedtabs#

2/2

(100%

)DHA

(50,83,75),

(59,90,87)and

(74,58),

Piperaquine

(108,100,111),

(98,108,108),

(107,97)

Twosampleslabeledas“2daysmalaria

treatm

ent”

“Artekin”and“Holleykin

Pharm

aceuticalCo.Ltd”Guangdong,

China,Lotnumbers

011206and010707.

Packagingappearedto

begenuine.

Allhad£90%

DHA

thanthatstated,

andonehadpiperaquine>110%

Unknown

üSubstandard

<85%

Cambodia

Oralartesunate

(200mg)+

mefloquine(250mg)

co-blisteredtabs#

1/1

(100%

)Artesunate

81and

124,Mefloquine

108%

.

Oneunitlabeledas“Malarine”Lot337116.

Artesunate

tabsembossed“Mepha.”

Unknown

+

Artesunate

PQ

<85%

>115%

Cambodia

Oralartesunate

(50mg)+

mefloquine(unknown)

co-blisteredtabs#

1/1

(100%

)Artesunate

(90,87,93,83)and

(86,88,93,84)

Twounitslabeledas“A

+M4”Lot00618.

Mefloquinetabletswere

missing.

Unknown

+

Artesunate

PQ

<85%

Cambodia

Oralartemether/40mg/cap#

0/1

(0%

)−

Oneunitlabeledas“Kunming

Pharm

aceuticalCo.Ltd,”

Lot07GE1.

Unknown

üAuthentic

LaoPDR

Oralchloroquinephosphate/

250mg/tab#

1/1

(100%

)Chloroquine

(107,117,116,

116%

)

Fourunitslabeledas“MALACIN

”made

by“A.N

.B.LaboratoriesCo.Ltd,”

LotNo.500751.Packaging

appearedgenuine.

Unknown

üSubstandard

>115%

LaoPDR

Oralquininesulfate/m

g/tab

notstated.Assumedto

be250mg/tab#

9/10(90%

)Quinine

(95,61,74,70),

(86,71,74,81),

(83,77,72,75),

(71,70,61,71),

(70,62,75,71),

(69,76,80,81),

(80,75,77,76),

(79,75,72,77),

(75,80,83,84)


Ninesetsof19–22whitetabletsin

plastic

bagsw/o

identity

labeling.Batch

numbernotstated.Stateddose

assumed.A

Unknown

+

PQ

<85%

Sample


Oneunitof22whitetabletsin

plastic

bagsw/o

identity

labeling.Stated

dose

assumed

+

90–110%

LaoPDR

Oralsulfadoxine

(500mg)-pyrimethamine

(25mg)coform

ulatedtabs#

3/3

(100%

)Sulfadoxine

(95,105,94),

(139,174)

Twosampleslabeledas“Mekofan”made

by“CTCPHoa-D

uocpharm

Mekophar.”

Lotnumbers

0021104,0010405.

Unknown

+

PQ

Pyrim

<85%

Pyrimethamine

(84,45,47),

(94,87)

Sulfa>115%

Sulfadoxine

(76,88,89),

(72,89,56)

Twounitslabeledas“Tancida”(2).

Lotnumberorexpirydate

0412.

+

PQ

Pyrim

<85%

Pyrimethamine

(84,45,46),

(84,43,24)

Sulfa<85%

(continued)

SUPPLEMENTALTABLE1

Continued

OperationStorm

II

Country/source

Medicine/m

gperunit

No.offailed

samples(90–110%

)/no.collected(%

failed)

Chemicalassay

detailsforfailed

samples(actual%

API)

Notesandpackaging

Seizure

location

Authenticpackaging

anddosage

form

savailable

LaoPDR

Oralartesunate/50mg/tab#

1/5

(20%

)(115,114,113)

Sample


Unknown

Onesample

labeledas“Artesunat”

madeby“Mekophar.”Lot07006FN.

Packagingappearedgenuine.

üSubstandard

>110%


Threesamples(7

units)

labeledas

“Artesunat”

madeby“Mekophar.”

Lot07006FN

and09001FN,08001FN.

üAuthentic

Twounitslabeledasmadeby

“PHARBACO.”

Lot011207.

+

90–110%

LaoPDR

ivquininedihydrochloride/

600mg/vial#

0/1

(0%

)−

Oneunitlabeledasmadeby“ANB.”

Exp.

Date

10/2011,07/2011,04/2013,04/2012.

Unknown

üAuthentic

LaoPDR

ivartesunate

(60mg)vialand

5%

sodium

bicarbonate

#0/1

(0%

)−

Oneunitlabeledasmadeby“Guilin

Pharm

aceuticalCo.Ltd”LotZA061102

forartesunate

andT061101forbicarbonate.

Bicarbonate

notanalyzed.

Unknown

üAuthentic

Thailand

Oralchloroquinephosphate/

250mg/tab

2/4

(50%

)65.8

and62.1


Onesample

labeledas“CHLOROQUIN

EPHOSPHATETABLETS.”

Manufacturer

andbatchnumbernotstated.

MaesodDistrict,

Tak

+

PQ

<85%

Onesample

withloose

tabletspackedin


labeling.

Indicatedas“Chloroquinephosphate

250mg”withbatchnumber18139bythe

submitter.Manufacturernotstated.

MaesodDistrict,

Tak

+

PQ

<85%


Onesample

labeledas“MALACIN

”by

“A.N

.B.LaboratoriesCo.,Ltd”withbatch

number500751.

MuangDistrict,

Ranong

+

90–110%

Onesample

labeledas

“CHLOROQUIN

EPHOSPHATE

TABLETS.”

Manufacturerandbatch

numbernotstated.

MuangDistrict,

Ranong

+

90–110%

Thailand

Oralchloroquine/m

g/tab

notstated.Assumedto

be250mg/tab

1/1

(100%

)71.6%

(179.1

mg/tab)

Loose

tabletspackedin

ziplocakbaglabeled

as“10/11/09;Chloroquine;18079.”


MuangDistrict,

Ranong

+

PQ

<85%

Thailand

Oralquininesulfate/m

g/tab

notstated.Assumedto

be250mg/tab

1/1

(100%

)116.7%

(291.8

mg/tab)

Loose

tabletspackedin

plasticbagwithout

identity

labeling.Indicatedas“Quinne-S”

bythesubmitter.Manufacturerandbatch

numbernotstated.

MaesodDistrict,

Tak

+

>115%

API=activepharm

aceuticalingredient;CDC=CenterforDisease

ControlandPrevention;DHA

=dihydroartemisinin;HSA

=HealthSciencesAuthority;PQ

=poorquality

(insufficientevidence

todeterm

inewhetherfalsifiedorsubstandard).

AllassayedatHSA,except#thatwere

assayedatCDCandGeorgia

Tech,Atlanta,GA.Availabilityofauthenticreference

sample:ü

available;

+notavailable.

Thecriteriaof85–115%

and90–110%

APIhavebeenusedforinterpretation.T

hose

thatfailedusing85–115%

APIcriteriaare

givenin

red.90–110%

indicatesthatthesample

had%

APIwithin

thisrangebutauthenticpackagingexampleswere

notavailable

toallowconfirm

ationthatsample

wasauthentic.

Documents

110% 85% 90% 85% (continued) PQ - Semantic Scholar€¦ · 81.1 One unit labeled as “AMOXICO(TM)- 500” by “Plethico Pharmaceuticals Limited,” batch number 06533. Preah Vihear