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Pan Pharmaceuticals busted

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Safety breaches force recall
By Judy Skatssoon
April 28, 2003

AUSTRALIANS have been warned against taking herbal, vitamin or nutritional supplements following the biggest recall of medical products in the country's history.

The national medicines watchdog, the Therapeutic Goods Administration (TGA), today suspended the licence of Pan Pharmaceuticals for six months and ordered the immediate withdrawal of 219 of its products following a series of grave safety and quality breaches.

Pan is Australia's largest contract manufacturer of herbal, vitamin and nutritional supplements.

It also makes some over-the-counter medicines including paracetamol, codeine, antihistamines and pseudoephedrine.

Pan represents 70 per cent of the Australian complementary medicine market and exports to dozens of countries.

The number of products recalled could blow out to several thousand in coming days.

TGA principal medical adviser Dr John McEwen said other products manufactured by Pan but sold under different brand names would be added to the list as they were discovered.

Dr McEwen said Pan lost its license following evidence of substitution of ingredients, manipulation of test results and substandard manufacturing processes.

He cited five instances where Pan released products containing raw materials that had not been tested for their safety and four cases where laboratory test results were manipulated to meet specifications.

There were also four recent examples of test results of an export vitamin product being fabricated.

Dr McEwen also said on several occasions beef cartilage had been substituted for shark cartilage in a shark cartilage preparation.

"Our great worry is that a product may not be true to label," he said.

"It may have a herb in it that has not been appropriately tested and may have a contaminant in it that could cause a serious illness ... or potentially fatal allergic reaction."

Pan first came to the attention of the TGA over its travel sickness tablet Travacalm, which was recalled in January, Parliamentary health secretary Trish Worth said.

Faulty batches of the tablets resulted in at least 87 adverse reactions and 19 hospitalisations.

In some cases people attempted to jump out of planes or off boats because they were experiencing severe hallucinations, Ms Worth said.

The Travacalm incident led to further investigations which found the problems highlighted with the Travacalm tablets were "endemic" at Pan, Ms Worth said.

"There were substitutions, there was manipulation of data and it was a very sorry tale indeed."

"There will be further investigations ... and it's possible that criminal charges will be laid."

Regulatory authorities in other countries were being informed of the development, Dr McEwen said.

He said the TGA would publish a list of recalled products in newspaper advertisements and on its websites over the next few days.

Until then, consumers should avoid taking herbal and vitamin preparations, Dr McEwen said.

"Until people have had a chance to check the newspaper advertisements, both tomorrow and later advertisements which may be at the end of the week or early next week, they should avoid taking their complementary or vitamin products unless there is some very special reason," he said.

People should also avoid taking all but the most reputable over-the-counter brands of painkillers and cold and flu preparations, Dr McEwen said.

However, he stressed consumers should not stop taking prescription medicines or PBS pharmaceuticals.

Pan would be able to regain its licence after six months if it could demonstrate it had cleaned up its act, he said.

Shares in Pan Pharmaceuticals plummeted 29 cents to $1.20, representing a fall of 19.5 per cent, ahead of a trading halt following the TGA announcement.

Comment was being sought from Pan.

Full list of recalled products

AAP

http://news.com.au/common/story_page/0,4057,6349938%5E2,00.html
 
PRODUCT NAME (in alphabetical order)

73951
21ST CENTURY DELICIOUS CHILDREN'S MULTI VITAMINS & MINERALS TASTY ORANGE Tablet - effervescent tube

91608
3 G's

93620
ACID AID

90560
ANOXIVIT

91262
AUSDANT Q10

91075
AUSHARK

90927
B GROUP + C EFFERVESCENT TABLETS

92066
BEVON-C

90552
BREWERS YEAST 1000mg

90559
CALCI - BONE

93621
CALCIUM 300mg IN COD LIVER OIL

91119
CALCIUM CHILDREN CHEWABLE COMPLEX

91264
CALCIUM GLUCONATE 300mg CHEWABLE

91609
CALCIUM ISOFLAVONE COMPLEX

93622
CALCIUM, MAGNESIUM, ZINC

90558
CARDIOVIT

91121
CHILDCARE CHILDRENS MULTIVITAMINS & MINERALS

93017
CHILDREN MV-LYSINE

90550
CHILDREN'S C

91117
CHILDREN'S CHEWABLE ECHINACEA COMPLEX

91068
CHILDREN'S CHEWABLE MULTIVITAMINS AND MINERALS COMPLEX

91120
CHILDREN'S CHEWABLE VITAMIN C COMPLEX TABLETS - ORANGE FLAVOUR

90933
CHILDREN'S MULTI

93981
CHILDREN'S MULTIVITAMIN & MINERALS CHEWABLE TABLET

92265
COD LIVER OIL ONE-A-DAY

92266
COD LIVER OIL PLUS MULTIVITAMINS

90561
COD LIVER OIL WITH MULTIVITAMINS

90547
CO-ENZYME Q10

92810
CONTRAVIT FORMULA

93509
CRANBERRY 5000 EFFERVESCENT TABLET

93619
DOLOMITE TABLETS 1g

90553
E.P.O + VIT. E

91295
ECHA - C

90516
ELLY 1000

91432
EVENING PRIMROSE OIL 1.3g CAPSULES

90931
EVENING PRIMROSE OIL 1000mg CAPSULES

92269
EVENING PRIMROSE OIL 600mg CAPSULES

90794
FERRO 4

90549
FOLAVIT

91073
FondAKids (Dinosaur shape)

91072
FondAKids (Koala shape)

90793
GARLIC + LECITHIN

92264
GARLIC PEARLS (ENTERIC COATED)

92267
GARLIC WITH ANTIOXIDANT

92809
GENTLE C

91071
GINKGO BILOBA WITH DHA

83323
GLUCOSAMINE AND CHONDROITIN COMPLEX TABLETS

90563
HAIR FORMULA

93511
HIMEE VITAMIN C 250mg TABLET

93510
HIMEE VITAMIN C 500mg TABLET

91074
KALCIMEX-D

91297
LIQUID ADULTS COUGH SYRUP (WITH HONEY)

91298
LIQUID IRON

91296
LIQUID ROYAL JELLY

93623
LIVITRON CAPSULES

92807
LYCOPENE 6mg

93512
M-TONE TABLETS

90562
MULTIVITAMIN & MINERAL

91069
NATOXI PLUS

91431
NATURAL VITAMIN E 1000IU

76351
NATURALLY HERBAL SIBERIAN GINSENG 1000 Tablet - uncoated bottle

76352
NATURALLY HERBAL SIBERIAN GINSENG 500 Tablet - uncoated bottle

90463
Nn CALCIUM PLUS

90314
Nn Chewable C - 500mg

90465
Nn NON-ACIDIC C-PLUS

93514
NON ACIDIC C

91438
OMEGA 3 FISH OIL 500mg + EPO 500mg + NATURAL VITAMIN E 100IU

91433
OMEGA-3 FISH OIL 1.2g

82191
PAN ACID FREE 500MG COMPLEX Tablet - film coated bottle

83264
PAN ACIDOPHILUS PLUS ENTERIC COATED CAPSULES Capsule, enteric not applicable

80456
PAN ALOE VERA CONCENTRATE Aloe barbadensis 25mg Capsule, soft bottle

83259
PAN ALPHA LIPOIC ACID 300MG R,S-alpha Lipoic acid 300mg Tablet - film coated not applicable

83266
PAN AMEGO 1000 Fish oil - natural 1g Capsule, soft not applicable

78511
PAN APEVIT Tablet - film coated bottle

83270
PAN ARTEC Tablet - film coated not applicable

81103
PAN ARTHRI-CARE GLUCOSAMINE SULFATE Glucosamine sulfate-potassium chloride complex 500mg Tablet - film coated bottle

81104
PAN ARTHRI-CARE GLUCOSAMINE SULFATE PLUS Tablet - film coated bottle

81675
PAN ARTHRI-CARE SHARK CARTILAGE Shark cartilage 400mg Tablet - film coated bottle

78073
PAN BECOFORTE SUPER Tablet - film coated blister pack

77538
PAN BETACAROTENE 15MG Betacarotene 15mg Tablet - film coated bottle

82673
PAN BILBERRY 5000 Vaccinium myrtillus 50mg Capsule, soft bottle

77896
PAN BIO VIT C Tablet - film coated bottle

80796
PAN CALCIUM AND MAGNESIUM TABLETS Tablet - film coated bottle

80454
PAN CELERY SEED OIL Celery Seed Oil 25mg Capsule, soft bottle

77442
PAN CHEWABLE VITAMIN E PLUS SELENIUM Tablet - chewable bottle

82043
PAN CHILDREN'S MULTI DROPS Oral Liquid bottle

82038
PAN CHILDREN'S MULTIVITAMIN & MINERAL LIQUID (CITRUS FLAVOUR) Oral Liquid bottle

82674
PAN CO-ENZYME Q10 100MG Ubidecarenone 100mg Capsule, soft bottle

83261
PAN CO-ENZYME Q10 150MG COMPLEX Capsule, soft not applicable

78022
PAN CO-ENZYME Q10 30MG FIZZY Ubidecarenone 30mg Tablet - chewable bottle

77041
PAN CO-ENZYME Q10 30MG Ubidecarenone 30mg Capsule, soft bottle

78019
PAN CO-ENZYME Q10 30MG WATER SOLUBILISED Ubidecarenone 30mg Capsule, soft bottle

79628
PAN CO-ENZYME Q10 50MG COMPLEX WATER SOLUBILIZED Capsule, soft bottle

78028
PAN COMPUTER EYE Capsule, soft bottle

77445
PAN DERMA NUTRITION 1 Capsule, soft bottle

77444
PAN DERMA NUTRITION 2 Capsule, soft bottle

90177
PAN DIGEST-ADE

77446
PAN DIGEST-ADE Tablet - film coated bottle

79629
PAN ECHINACEA COMPLEX Capsule, soft bottle

83026
PAN EPO 500MG WITH FLAXSEED OIL 500MG Capsule, soft bottle

82088
PAN EVENING PRIMROSE OIL 500mg CAPSULES

80473
PAN EVENING PRIMROSE OIL 600MG CAPSULES Evening Primrose Oil 600mg Capsule, soft bottle

81102
PAN FAVIT WOMEN BEAUTY - SKIN PLAN Capsule, soft bottle

78053
PAN FLAXSEED OIL 1000MG Linseed Oil 1g Capsule, soft bottle

79810
PAN FOLIC ACID 400MCG PLUS VITAMIN B12 500MCG FIZZY Tablet - chewable bottle

83269
PAN FOLIC ACID 500MCG Folic acid 500microgram Capsule, soft not applicable

76355
PAN FOLIC ACID 500mcg Folic acid 500microgram Tablet - uncoated bottle

80449
PAN GARLIC 20,000 Garlic Oil 6.67mg Capsule, soft bottle

80448
PAN GARLIC 3,000 Garlic Oil 1mg Capsule, soft bottle

83265
PAN GARLIC PEARLS ENTERIC COATED Garlic Oil 1mg Capsule, enteric not applicable

90468
PAN GINGER 500mg TABLETS

74022
PAN GINKGO 6000 TABLETS Ginkgo biloba 120mg Tablet - film coated bottle

81576
PAN GINKGO BILOBA 2.4G CAPSULES Capsule, hard bottle

78025
PAN GINKGO BILOBA 7500 COMPLEX Capsule, soft bottle

74101
PAN GINKGO PLUS Capsule - soft bottle

78055
PAN GLUCOSAMINE AND CHONDROITIN COMPLEX Tablet - film coated bottle

90013
PAN GLUCOSAMINE SULFATE 1000mg

90467
PAN GLUCOSAMINE SULFATE 1000mg TABLETS

90012
PAN GLUCOSAMINE SULFATE 500mg

81582
PAN INULIN 500MG CAPSULES Inulin 500mg Capsule, hard bottle

78054
PAN JOINT USE (FLAXSEED, OMEGA + EVENING PRIMROSE OIL) Capsule, soft bottle

78026
PAN JUNIOR DHA COMPLEX Capsule, soft bottle

83260
PAN KALI PHOS Potassium phosphate - monobasic 500microgram Tablet - uncoated not applicable

76353
PAN L - LYSINE 500MG Lysine hydrochloride 624mg Tablet - uncoated bottle

82839
PAN L-CARNITINE 250MG Levocarnitine fumarate 431mg Capsule, soft not applicable

76354
PAN L-CYSTEINE 500MG Cysteine hydrochloride 650.4mg Tablet - film coated bottle

80450
PAN LECITHIN 1200MG Lecithin 1.2g Capsule, soft bottle

80455
PAN LECITHIN PLUS E Capsule, soft bottle

80457
PAN LEVATONE Capsule, soft bottle

79630
PAN LIVATONE Capsule, soft bottle

78023
PAN LIVER TONIC Capsule, soft bottle

83263
PAN MEGA ANTI-OXIDANT FORMULA Capsule, soft not applicable

83268
PAN MILK THISTLE 150MG Silybum marianum 37.5mg Capsule, soft not applicable

83267
PAN MINTEC CAPSULES (ENTERIC COATED) Peppermint Oil 180mg Capsule, enteric not applicable

83324
PAN NATURAL E 400IU +SELENIUM & FOLIC ACID Capsule, soft not applicable

82677
PAN NATURAL VITAMIN E 200IU d-alpha-Tocopherol 134.2mg Capsule, soft bottle

77533
PAN NATURAL VITAMIN E 250IU d-alpha-Tocopherol 167.8mg Capsule, soft bottle

79699
PAN NATURAL VITAMIN E 400IU d-alpha-Tocopherol 268.5mg Capsule, soft bottle

77535
PAN NATURAL VITAMIN E 400IU d-alpha-Tocopheryl acetate 294.1mg Capsule, soft bottle

82678
PAN NATURAL VITAMIN E 500IU d-alpha-Tocopherol 335.6mg Capsule, soft bottle

78074
PAN NATURAL VITAMIN E 600IU d-alpha-Tocopheryl acetate 441.2mg Capsule, soft bottle

77537
PAN NEUTRAL C TIME RELEASE 1000MG COMPLEX Tablet - modified release bottle

77536
PAN NEUTRAL C TIME RELEASE 500MG COMPLEX Tablet - modified release bottle

82924
PAN ODOURLESS GARLIC Garlic Oil 1mg Capsule, soft not applicable

76779
PAN O'FRESH TABLETS Chlorophyll CI75810 60mg Tablet - uncoated bottle

77443
PAN OLIVE PLUS Tablet - film coated bottle

82676
PAN OMEGA - 3 FISH OIL 1000MG ENTERIC COATED Fish oil - natural 1g Capsule, enteric bottle

80451
PAN OMEGA 3 Fish oil - natural 1g Capsule, soft bottle

80472
PAN OMEGA 3 FISH OIL 1000MG CAPSULES Fish oil - natural 1g Capsule, soft bottle

74669
PAN PALMETTO PLUS Tablet - film coated bottle

80005
PAN PHYTO-CARE CAPSULES Glycine max 43.75mg Capsule, hard bottle

81154
PAN PHYTROL 450MG Phytosterol complex - conifer 450mg Tablet - uncoated bottle

83258
PAN PROPOLIS 1000 Propolis 200mg Capsule, soft not applicable

78021
PAN PROPOLIS 500MG Propolis 100mg Capsule, soft bottle

76137
PAN PROPOLIS 650MG CAPSULES Propolis 130mg Capsule, soft bottle

83262
PAN ROBOVIT CHILDRENS MULTIVITAMINS PLUS ZINC STRAWBERRY FLAVOUR Tablet - chewable not applicable

80154
PAN ROOTAMIN Orange, Lemon and Strawberry flavour tablet bottle

80453
PAN ROYAL JELLY 1000MG Royal jelly 333.33mg Capsule, soft bottle

80452
PAN ROYAL JELLY 500MG Royal jelly 167mg Capsule, soft bottle

90061
PAN SALMON - E

82675
PAN SAM-E Ademetionine disulfate tosylate 400mg Tablet - enteric coated bottle

90176
PAN SILYMARIN WITH VITAMINS

81581
PAN ST JOHN'S WORT 1.2G CAPSULES Hypericum perforatum 200mg Capsule, hard bottle

81184
PAN STRIKE -A- COLD AND FLU Capsule, soft blister pack

81185
PAN STRIKE -A- COLD Capsule, soft blister pack

78027
PAN SUPER EPA Fish oil - natural 1g Capsule, soft bottle

74102
PAN SUPER SLIM Capsule - hard bottle

82089
PAN SUPERIOR CELERY COMPLEX Capsule, soft bottle

82090
PAN SUPERIOR OMEGA-3 COMPLEX Capsule, soft bottle

76295
PAN SUPERTON Capsule, soft bottle

78020
PAN TUNA OIL 1000MG Fish oil - natural 1g Capsule, soft bottle

78024
PAN VARI-X Capsule, soft bottle

79545
PAN VITAMIN C 500MG ACID-FREE WITH BIOFLAVONOIDS S/R Tablet - modified release bottle

75696
PAN VITAMIN C PLUS ECHINACEA & GARLIC Tablet - film coated bottle

78056
PAN VITAMIN E 200IU SYNTHETIC dl-alpha-Tocopheryl acetate 200mg Capsule, soft bottle

78057
PAN VITAMIN E 400IU SYNTHETIC dl-alpha-Tocopheryl acetate 400mg Capsule, soft bottle

71610
PANLABS CO - ENZYME Q10 30MG WATER SOLUBILIZED Ubidecarenone 30mg Capsule - soft bottle

73364
PANLABS COD LIVER OIL 275MG CAPSULE Cod-liver oil 275mg Capsule - soft bottle

66926
PANLABS EVENING PRIMROSE OIL 1000MG Evening Primrose Oil 1g Capsule - soft bottle

66393
PANLABS GINKGO BILOBA 2000 Ginkgo biloba 40mg Capsule - hard bottle

65958
PANLABS MULTIVITAMIN & MINERAL Capsule - soft bottle

66392
PANLABS OMEGA-3 Fish oil - natural 1g Capsule - soft bottle

71239
PANLABS SAW PALMETTO PLUS Capsule - soft bottle

66383
PANLABS SHARK CARTILAGE 750MG CAPSULES Shark cartilage 750mg Capsule - hard bottle

71244
PANLABS TRIBULUS PLUS Tablet - film coated bottle

66395
PANLABS VITAMIN C 1000MG SLOW RELEASE Ascorbic acid 1g Tablet - modified release bottle

73366
PANLABS VITAMIN C 1000MG WITH ROSEHIPS Tablet - film coated bottle

73377
PANLABS VITAMIN C 250MG NATURAL ORANGE FLAVOUR Tablet - chewable bottle

73367
PANLABS VITAMIN E 1000MG dl-alpha-Tocopheryl acetate 1g Capsule - soft bottle

93624
PREGNANCY & BREASTFEEDING

92268
PREGNANCY CAPSULES

91010
PRELAVIT

92065
PROFAMOL

90466
REDUCOL

92064
REVITA

90551
ROBOVIT

91118
ROBOVIT CHILDREN'S CHEWABLE MULTIVITAMINS AND MINERALS COMPLEX

90556
ROJETON

93513
ROYAL JELLY & SQUALENE

93618
SHARK CARTILAGE + SQUALENE

91436
STARFLOWER (BORAGE) OIL 1.3g

91435
STARFLOWER (BORAGE) OIL 1000mg

91434
STARFLOWER (BORAGE) OIL 500mg

90929
SUPER B 50

90932
SUPER CO-ENZYME Q10

90557
SUPERBOOST

92808
THERMOGENIC PLUS

93983
TOTAL IMAGE SHARK OIL 1000mg

91070
TRI-O-GEN PLUS

90555
URICRAN

93982
VITALIZER 1000mg

90464
VITAMIN C

90554
VITAMIN C 500mg

91263
VITAMIN C 500mg TABLETS ORANGE FLAVOURED

90926
VITAMIN C EFFERVESCENT TABLETS

90548
VITAMIN E 500IU

93984
VITAMIN E NATURAL 100IU

91437
WHEAT GERM OIL 1000mg

90928
WOMEN'S MULTI
 
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