OVARID TABLETS

Main information

  • Trade name:
  • OVARID TABLETS 5MG MEGESTROL ACETATE B.P.
  • Pharmaceutical form:
  • ORAL TABLET
  • Units in package:
  • 200Tab
  • Class:
  • Veterinary Medicine
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • INTERVET AUSTRALIA

Documents

Localization

  • Available in:
  • OVARID TABLETS 5MG MEGESTROL ACETATE B.P.
    Australia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • CAT | DOG | DOG - FEMALE (BITCH) | BITCH | CASTRATE | CAT - QUEEN | CAT - TOM | KITTEN | PUPPY
  • Therapeutic area:
  • hormone
  • Therapeutic indications:
  • EOSINOPHILIC GRANULOMAS | IMPROVING BEHAVIOUR | MAMMARY TUMOURS | MILIARY ECZEMA | MODIFY HYPERSEXUALITY | POSTPONE OESTRUS | PREVENT OESTRUS | PSEUDO-PREGNANCY | URINE SPRAY | ELIMINATE URINE SPRAYING | EXCESS LIBIDO - REDUCE | PSEUDO-CYESIS | PSEUDO-PREGNANCY LACTATION
  • Product summary:
  • For postponement or prevention of oestrus & treatment of false pregnancy and oestrogen-dependent mammary tumors in bitches. For oestrus control and treatment of miliary eczema and oesinophilic granuloma in cats. For the treatment of behavioural abnormalitNot recommended in diabetic animals. See DIRECTIONS FOR USE on leaflet also.

Other information

Status

  • Source:
  • Australian Pesticides and Veterinary Medicines Authority (APVMA)
  • Authorization status:
  • Registered and available
  • Authorization number:
  • 36149/1298
  • Authorization date:
  • 15-12-1998
  • Last update:
  • 15-06-2017

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

____________________________________________________________________________________________________

i:\wp\labels\ovarid5.doc:03/09/99

Page 1 of

INFOPEST – Company Supplied Label

OVARID 5MG

CARTON FRONT & REAR

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

Ovarid® tablets 5 mg

MEGESTROL ACETATE B.P.

For the postponement or prevention of oestrus and the

treatment of false pregnancy and oestrogen-dependent

mammary tumours in bitches. For oestrus control and for the

treatment of miliary eczema and oesinophilic granuloma

(rodent ulcer) in cats. For the treatment of behavioural

abnormalities, such as hypersexuality in male dogs and urine

spraying in cats.

200 tablets

JUROX

____________________________________________________________________________________________________

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Page 2 of

OVARID 5MG

CARTON SIDE (1)

READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT.

Made in Australia by

JUROX LOGO

Jurox Pty. Ltd.

Unit 22, Slough Estate, Holker St.,

Silverwater, NSW, 2128, Australia

Under licence from:

Schering-Plough Animal Health

® Schering-Plough Animal Health Limited Registered Trade Mark

____________________________________________________________________________________________________

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Page 3 of

OVARID 5MG

CARTON SIDE (2)

DISPOSE of container by wrapping in paper and putting in garbage.

STORE below 30

C (Room Temperature) in a dry place.

EXP.

NRA 36149/1298

____________________________________________________________________________________________________

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Page 4 of

OVARID 5MG

CARTON FLAPS (BOTTOM AND TOP)

Ovarid® tablets 5 mg

200 tablets

____________________________________________________________________________________________________

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Page 5 of

OVARID 5MG

FOIL

FOR ANIMAL TREATMENT ONLY

OVARID®

5 mg MEGESTROL ACETATE

JUROX

[B]

[E]

NRA 36149/1298

____________________________________________________________________________________________________

i:\wp\labels\ovarid5.doc:03/09/99

Page 6 of

OVARID 5MG

LEAFLET

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

Ovarid

® Tablets 5mg Megestrol Acetate B.P.

Ovarid

® Tablets 20mg Megestrol Acetate B.P.

Description

Each tablet contains megestrol acetate (6 methyl-

–17 acetoxy progesterone) in a dried yeast

base. Two strengths are available:-

20 mg tablets, packed in silver foil.

5 mg tablets, packed in gold foil.

Indications

Megestrol

acetate

potent

progestagen

with

marked

anti-oestrogenic

properties.

recommended for administration by the oral route in bitches for the postponement or prevention of

oestrus and the treatment of false pregnancy and oestrogen-dependent mammary tumours. In cats it

is recommended for oestrus control and for the treatment of miliary dermatitis and oesinophilic

granuloma (rodent ulcer). It can also be used in dogs and cats for the treatment of behavioural

abnormalities such as hypersexuality in male dogs and urine spraying in cats.

Postponement of oestrus (Bitches)

Ovarid tablets may be used to postpone an anticipated oestrus. Following the recommended course

it is not possible to state, with any degree of accuracy, when the next oestrus period will occur as this

will depend on the stage of anoestrus when the tablets were administered. It is most likely,

however, that it will appear some three months later. It is unlikely that oestrus will be delayed by

more than six months.

Extended postponement of oestrus (Bitches)

Experimentation has shown that oestrus can be postponed safely for longer periods of time by an

extended dosage regimen. In this case a full forty day postponement course of Ovarid should be

given starting in anoestrus, preferably 14 but at least 7 days before the effect is required. At the end

of the period treatment may be continued on a twice weekly basis as long as it is desired to postpone

oestrus, but not exceeding four months. Oestrus will not occur whilst bitches are receiving the tablets,

but as is the case with the shorter dosage regimen, it is not possible to say exactly when oestrus will

occur after withdrawal of the tablets. In the majority of bitches however, this interval is likely to be

about two to three months.

Suppression (prevention) of oestrus (Bitches)

When the tablets are used by the recommended method for the prevention of oestrus, the signs of

pro-oestrus usually disappear in two to three days and the subsequent oestrus normally occurs four to

six weeks earlier than would have been the case had medication not been given.

Treatment of false Pregnancy (Bitches)

Ovarid tablets will in most cases alleviate the physical and nervous signs of false pregnancy within

three days. In a small percentage of treated cases the signs of false pregnancy may recur some

three to six weeks later. This incidence can be minimised by commencing treatment immediately the

signs are seen. Treatment with Ovarid is least effective in cases which have recurred. Ovarid should

not be used in cases which have been recently treated with oestrogens. Experience has shown that

bitches can conceive normally at the subsequent heat following the withdrawal of Ovarid.

____________________________________________________________________________________________________

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Page 7 of

OVARID 5MG

LEAFLET (continued)

Oestrus control in Cats

Oestrus can be prevented or postponed by selecting an appropriate dose regimen. It should be

recognised that the cat is seasonally polyoestrus and that ovulation is induced by coitus, as these

factors may affect the occurrence of oestrus after treatment.

Miliary eczema in Cats

In the past corticosteroids and sex hormones have been used in the treatment of miliary eczema but

the results have been inconsistent. Field experience with Ovarid, however, has shown it to be very

successful. A response being noticed, in most cases, within the first few days of commencing

treatment. It should be recognised that other factors, such as flea infestation and diet may play a role

in the aetiology of miliary eczema.

Eosinophilic granuloma (rodent ulcer) in Cats

Some veterinary surgeons have found that Ovarid can be beneficial in this condition.

Oestrogen-dependent mammary tumours in Bitches

It has been found that Ovarid will reduce the size of these tumours. It has also been noted that the

blood supply to the neoplasm is often reduced. It becomes more circumscribed and thus surgical

removal can be more easily accomplished.

Control of behavioural abnormalities in the Dog and Cat

Ovarid has been used beneficially in the treatment of a number of behavioural abnormalities in the

dog and cat.

DIRECTIONS FOR USE

A slight change of temperament may be noted in a few animals while they are receiving the

tablets. In some cats dosage with Ovarid may cause temporary increase in weight.

A reversible diabetes-like syndrome may develop with prolonged continuous use of Ovarid. This

condition is reversible on cessation of treatment. Ovarid is not recommended in diabetic animals.

Progestagens, like other synthetic hormones, should always be used with care. This is particularly so

in bitches treated at their first oestrus. Owners should be advised that this class of bitch and a small

proportion of others which have abnormal oestrus cycles may show excessive libido or oestrus may

return earlier than expected because of difficulties which may be encountered with the timing of

administration. Apart from these considerations experience has shown that, when used correctly,

Ovarid tablets do not produce undesirable side effects since oral administration allows the duration of

effect to more accurately controlled than is the case with depot injections.

The timing of administration is of great importance if the best results are to be obtained,

. In some

cases it may be necessary to use vaginal cytology to identify the stage of the oestrus cycle so that

correct dosing may be undertaken

. If Ovarid tablets are given once ovulation has occurred

megestrol acetate may aid conception.

1.

DOGS

Postponement of oestrus (Bitches)

(i)

Normal dosage regimen: 0.5mg/kg daily for a maximum period of forty days. The course of

tablets should be commenced preferably 14 days but at least 7 days before the effect is required and

should not be repeated more frequently than once every six months. The following table may be used

to help in dispensing tablets.

____________________________________________________________________________________________________

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Page 8 of

OVARID 5MG

LEAFLET (continued)

Weight of Bitch

5 mg Tablets

20 mg Tablets

In kg

In lbs

No. Daily

No. for

Maximum

Course

No. Daily

No. for

Maximum

Course

<5

5-10

10-15

15-20

20-30

30-40

40-50

50-60

<11

11-22

22-33

33-44

44-66

66-88

88-110

110-142

0.25

0.50

1.50

(ii)

Extended dosage regimen: 0.1 to 0.2 mg/kg twice weekly for a maximum period of four

months, following a forty day course as described above. Bitches should be allowed to have a normal

unmedicated oestrus before this course is repeated.

Suppression (prevention) of oestrus (Bitches)

The course of tablets should be commenced at the onset of pro-oestrus as indicated by the presence

of haemorrhage and vulval swelling. The stage of the oestrus cycle may be confirmed by the

examination of vaginal smears.

Normal dosage regimen: 2 mg/kg daily for eight days.

Extended dosage regimen: 2 mg/kg daily for four days followed by 0.5 mg/kg daily for sixteen

days.

The use of this prolonged prevention course may be beneficial in bitches with a history of false

pregnancy. In some cases where other abnormalities of the oestrus cycle are known to occur, in first-

season bitches and when the animal to be medicated is housed with other bitches.

The following table may be used as a dosage guide and to help in dispensing tablets.

Weight of Bitch

5 mg Tablets

20 mg Tablets

In kg

In lbs

No. Daily

No. for

Complete

Course-8

days

No. Daily

No. for

Complete

Course-8

days

<1

1-2.5

2.5-5

5-7.5

7.5-10

10-15

15-20

20-25

25-30

30-35

35-40

40-50

50-60

<2

6-11

11-17

17-22

22-33

33-44

44-55

55-66

66-77

77-88

88-110

110-142

0.75

Treatment of false pregnancy

2 mg/kg daily for five to eight days commencing when signs of false pregnancy are first seen. In a

small percentage of treated cases the signs of false pregnancy may recur some three to six weeks

later. This incidence can be minimised by commencing the treatment immediately the signs are seen.

____________________________________________________________________________________________________

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Page 9 of

OVARID 5MG

LEAFLET (continued)

Oestrogen-dependent mammary tumours in bitches

The following dosage regimes have been used:

2 mg/kg daily for ten days, or

(ii)

2 mg/kg daily for five days, followed by 0.5 to 1.0 mg/kg daily for a further ten days.

Behavioural abnormalities – Dog and Cat

It will be necessary to vary the dose to suit individual cases.

As a guide the following dosage may be used:

5 days at 2 mg per kg and then

5 days at 1 mg per kg followed by

5 days at 0.5 mg per kg.

2.

CATS

Oestrus control in cats

(i)

Postponement of oestrus – dosage can commence in di-oestrus or anoestrus.

2.5 mg daily for two months (during breeding season).

2.5 mg once weekly for up to 18 months (during non-breeding season).

(ii)

Prevention of oestrus

5 mg daily for 3 days – commencing as soon as the signs of calling are seen. If necessary dosage

can be repeated at 21 day intervals at commencement of further calling.

Treatment of miliary eczema (miliary dermatitis) and oesinophilic granuloma (rodent ulcer) in

cats.

The recommended dosage is 2.5 to 5 mg every two to three days until the lesions begin to regress,

then once weekly until a satisfactory response is obtained. In some cases it may be necessary to

give a maintenance dosage of 2.5 mg weekly or fortnightly to prevent recurrence of the condition.

Administration

The yeast based tablets are readily accepted by most animals and consequently may be given intact

or crushed and mixed in a small quantity of food.

DISPOSE of container by wrapping in paper and putting in garbage.

STORE below 30

C (Room Temperature) in a dry place.

Aspinal, K.W. and Evans J.M. (1971) Vet. Rec. 88,374.

Fowler, N.G. and Foster, S.J. (1971) Vet Rec. 88,374.

Turner, W.T. (1971) Vet Rec., 88, 315.

Evans, J.M., Uvarov, O. and Vallance, D.K. (1969) Vet. Rec., 85 233, 234.

Pemberton, P.L. (1976) The Post-Graduate Committee in Veterinary Science.

The University of Sydney, Proceedings No. 30, Refresher Course in Neurology, pp. 11-27.

“A Glaxovet Guide to Ovarid”, 48pp. 1980.

Made in Australia by:

JUROX LOGO

Jurox Pty. Ltd.

Unit 22, Slough Estate, Holker Street, Silverwater, NSW 2128, AUSTRALIA

Under licence from Schering-Plough Animal Health Limited

® Limited Registered Trade Mark

Ovarid 5mg

NRA 36149/1298

Ovarid 20mg

NRA 36150/1298

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Health Canada

3-11-2018

Janssen Issues Voluntary Nationwide Recall for one lot of ORTHO-NOVUM 1/35 and two lots of ORTHO-NOVUM 7/7/7 Due to Incorrect Veridate Dispenser Instructions

Janssen Issues Voluntary Nationwide Recall for one lot of ORTHO-NOVUM 1/35 and two lots of ORTHO-NOVUM 7/7/7 Due to Incorrect Veridate Dispenser Instructions

Janssen Pharmaceuticals, Inc. has initiated a voluntary recall of one lot of ORTHO-NOVUM 1/35 (norethindrone / ethinyl estradiol) Tablets and two lots of ORTHO-NOVUM 7/7/7 (norethindrone / ethinyl estradiol) Tablets to the pharmacy level. The patient information provided inside affected packages of ORTHO-NOVUM does not include the appropriate instructions for the Veridate dispenser.

FDA - U.S. Food and Drug Administration

30-10-2018

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP  75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP 75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

ScieGen Pharmaceuticals, Inc. is voluntarily recalling listed lots, within expiry, of Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg dosage forms to the consumer level. These products are being recalled due to the presence of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Irbesartan, USP manufactured by Aurobindo Pharma Limited. This impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a...

FDA - U.S. Food and Drug Administration

30-10-2018

FDA takes action to stop the use of lead acetate in hair dyes

FDA takes action to stop the use of lead acetate in hair dyes

FDA takes action to stop the use of lead acetate in hair dyes. FDA will no longer allow lead acetate to be used in certain hair coloring products based on data that demonstrate that there is no longer a reasonable certainty of no harm from the use of this color additive.

FDA - U.S. Food and Drug Administration

29-10-2018

Big Penis U.S.A tablets

Big Penis U.S.A tablets

Big Penis U.S.A tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

8-10-2018

Glyceryl trinitrate tablets (Anginine and Lycinate)

Glyceryl trinitrate tablets (Anginine and Lycinate)

Update 3 - continuing medicine shortage

Therapeutic Goods Administration - Australia

28-9-2018

Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin® 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label

Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin® 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label

Endo International plc (NASDAQ: ENDP) today announced that one of its operating companies, Endo Pharmaceuticals Inc., is voluntarily recalling two lots of Robaxin® (methocarbamol tablets, USP) 750mg Tablets 100 Count Bottle pack to the consumer level. The products have been found to have incorrect daily dosing information on the label due to a labeling error which misstates the daily dose as "two to four tablets four times daily" rather than the correct dosage of "two tablets three times daily." (see pic...

FDA - U.S. Food and Drug Administration

27-9-2018

Oscor Inc. Issues Recall of TB – Temporary Bipolar Pacing Lead (Unshrouded 2 mm Pins Models)

Oscor Inc. Issues Recall of TB – Temporary Bipolar Pacing Lead (Unshrouded 2 mm Pins Models)

During the use of some TB - Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connectors, the connector cap housing (see Picture 1, No. 2 Pin Cap and Cover) may slide and potentially expose the connection wire. In some instances, this may cause the wire to be more susceptible to loss of connectivity or breakage during movement of the cables causing interruption of the pacing system. The analysis of the returned devices attributed the failure to a design change of the cap housing of the pins. ...

FDA - U.S. Food and Drug Administration

7-9-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

FDA - U.S. Food and Drug Administration

31-8-2018

FDA announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals due to incorrect drug in bottles

FDA announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals due to incorrect drug in bottles

FDA is warning the public about a voluntary recall of one lot of montelukast sodium tablets made by Camber Pharmaceuticals due to incorrect drug in bottles

FDA - U.S. Food and Drug Administration

28-8-2018

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market.

FDA - U.S. Food and Drug Administration

22-8-2018

Germany Niubian tablets

Germany Niubian tablets

Germany Niubian tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

22-8-2018

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets

Torrent Pharmaceuticals Limited is voluntarily recalling ALL LOTS within expiry of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industr...

FDA - U.S. Food and Drug Administration

18-8-2018

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets

Torrent Pharmaceuticals Limited is voluntarily recalling 14 lots of Valsartan/Amlodipine/HCTZ tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probabl...

FDA - U.S. Food and Drug Administration

15-8-2018

G Female Oral Tablets

G Female Oral Tablets

G Female Oral Tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

10-8-2018

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg to the wholesale level. These products are being recalled as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to the FDA’s Import Alert of Sichuan Friendly Pharmaceutical Co., Ltd., which as a result of a 2017 inspection were found to have deficiencies with Current Good Ma...

FDA - U.S. Food and Drug Administration

10-8-2018

FDA approves new vaginal ring for one year of birth control

FDA approves new vaginal ring for one year of birth control

FDA approved Annovera (segesterone acetate and ethinyl estradiol vaginal system), a combined hormonal contraceptive for women of reproductive age used to prevent pregnancy and is the first vaginal ring contraceptive that can be used for an entire year.

FDA - U.S. Food and Drug Administration

9-8-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)

As a precautionary measure, Camber Pharmaceuticals, Inc. is voluntarily recalling all unexpired lots of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg to the hospital, retail and consumer level. This recall of multiple batches of Valsartan Tablets was prompted due to the detection of trace amounts of N-Nitrosodimethylamine (NDMA), a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer).

FDA - U.S. Food and Drug Administration

17-7-2018

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets

Teva Pharmaceuticals USA today confirmed a voluntary recall to the consumer / user level of 29 lots of single and 51 lots of combination valsartan medicines distributed under the Actavis label in the U.S. due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceutical. The impurity detected in the API is N- nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking wat...

FDA - U.S. Food and Drug Administration

13-7-2018

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc. dba Solco Healthcare LLC. is recalling all lots of Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the retail level. This product recall is due to the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA), made by the manufacturer – Zhejiang Huahai Pharmaceutical Co. Ltd. -- that is used in the manufacture of the subject product ...

FDA - U.S. Food and Drug Administration

28-6-2018

Need for Seal tablets

Need for Seal tablets

Need for Seal tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

28-6-2018

Gold Maka tablets

Gold Maka tablets

Gold Maka tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

28-6-2018

One Night Lover tablets

One Night Lover tablets

One Night Lover tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

19-6-2018

Bulbao Male Enhancer tablets

Bulbao Male Enhancer tablets

Bulbao Male Enhancer tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

20-12-2018


Orphan designation: 1-(3-methylbutanoyl)-L-aspartyl-L-threonyl-L-histidyl-L-phenylalanyl-L-prolyl-(L-cystinyl-L-isoleucyl-[(N6-(S)-4-carboxy-4-palmitamidobutanoyl)-L-lysinyl]-L-phenylalanyl-L-glutamyl-L-prolyl-L-arginyl-L-serinyl-L-lysinyl-L-glycinyl-L-c

Orphan designation: 1-(3-methylbutanoyl)-L-aspartyl-L-threonyl-L-histidyl-L-phenylalanyl-L-prolyl-(L-cystinyl-L-isoleucyl-[(N6-(S)-4-carboxy-4-palmitamidobutanoyl)-L-lysinyl]-L-phenylalanyl-L-glutamyl-L-prolyl-L-arginyl-L-serinyl-L-lysinyl-L-glycinyl-L-c

Orphan designation: 1-(3-methylbutanoyl)-L-aspartyl-L-threonyl-L-histidyl-L-phenylalanyl-L-prolyl-(L-cystinyl-L-isoleucyl-[(N6-(S)-4-carboxy-4-palmitamidobutanoyl)-L-lysinyl]-L-phenylalanyl-L-glutamyl-L-prolyl-L-arginyl-L-serinyl-L-lysinyl-L-glycinyl-L-cystinyl)-L-lysinamide, disulfide, acetate salt, Treatment of beta-thalassaemia intermedia and major, 24/08/2018, Positive

Europe - EMA - European Medicines Agency

18-12-2018


Orphan designation: H-Phe-Ser-Arg-Tyr-Ala-Arg-OH acetate (Alirinetide), Treatment of amyotrophic lateral sclerosis, 30/05/2016, Positive

Orphan designation: H-Phe-Ser-Arg-Tyr-Ala-Arg-OH acetate (Alirinetide), Treatment of amyotrophic lateral sclerosis, 30/05/2016, Positive

Orphan designation: H-Phe-Ser-Arg-Tyr-Ala-Arg-OH acetate (Alirinetide), Treatment of amyotrophic lateral sclerosis, 30/05/2016, Positive

Europe - EMA - European Medicines Agency

18-12-2018

APO-Valsartan (valsartan) tablets

APO-Valsartan (valsartan) tablets

Recall - potential contamination

Therapeutic Goods Administration - Australia

10-12-2018

EU/3/16/1662 (QRC Ireland)

EU/3/16/1662 (QRC Ireland)

EU/3/16/1662 (Active substance: H-Phe-Ser-Arg-Tyr-Ala-Arg-OH acetate) - Transfer of orphan designation - Commission Decision (2018)8626 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/011/16/T/01

Europe -DG Health and Food Safety

23-11-2018

.@US_FDA issues Class I Medical Device Recall, the most serious type of   recall: Oscor Recalls TB Temporary Bipolar Pacing Leads Due to  Connector Separation Causing Potential for Loss of Pacing. Find out  more:  https://go.usa.gov/xPHxF  #FDA #MedicalDe

.@US_FDA issues Class I Medical Device Recall, the most serious type of recall: Oscor Recalls TB Temporary Bipolar Pacing Leads Due to Connector Separation Causing Potential for Loss of Pacing. Find out more: https://go.usa.gov/xPHxF  #FDA #MedicalDe

. @US_FDA issues Class I Medical Device Recall, the most serious type of recall: Oscor Recalls TB Temporary Bipolar Pacing Leads Due to Connector Separation Causing Potential for Loss of Pacing. Find out more: https://go.usa.gov/xPHxF  #FDA #MedicalDevice pic.twitter.com/negJ6HU4x2

FDA - U.S. Food and Drug Administration

21-11-2018

Osurnia (Elanco GmbH)

Osurnia (Elanco GmbH)

Osurnia (Active substance: terbinafine / florfenicol / betamethasone acetate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7842 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/003753/T/0010

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2086 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/18/2086 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/18/2086 (Active substance: Cyclo[L-alanyl-L-seryl-L-isoleucyl-L-prolyl-L-prolyl-L-glutaminyl-L-lysyl-L-tyrosyl-D-prolyl-L-prolyl-(2S)-2-aminodecanoyl-L-alpha-glutamyl-L-threonyl]acetate) - Orphan designation - Commission Decision (2018)7795 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/106/18

Europe -DG Health and Food Safety

1-10-2018

EU/3/03/133 (Shire Orphan Therapies GmbH)

EU/3/03/133 (Shire Orphan Therapies GmbH)

EU/3/03/133 (Active substance: Icatibant acetate) - Transfer of orphan designation - Commission Decision (2018)6432 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/054/02/T/01

Europe -DG Health and Food Safety

29-8-2018

Ulipristal Acetate Gedeon Richter (Gedeon Richter Plc.)

Ulipristal Acetate Gedeon Richter (Gedeon Richter Plc.)

Ulipristal Acetate Gedeon Richter (Active substance: Ulipristal Acetate) - Centralised - Authorisation - Commission Decision (2018)5779 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/5017

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2058 (IQVIA RDS Ireland Limited)

EU/3/18/2058 (IQVIA RDS Ireland Limited)

EU/3/18/2058 (Active substance: 1-(3-methylbutanoyl)-L-aspartyl-L-threonyl-L-histidyl-L-phenylalanyl-L-prolyl-(L-cystinyl-L-isoleucyl-[(N6-(S)-4-carboxy-4-palmitamidobutanoyl)-L-lysinyl]-L-phenylalanyl-L-glutamyl-L-prolyl-L-arginyl-L-serinyl-L-lysinyl-L-glycinyl-L-cystinyl)-L-lysinamide, disulfide, acetate) - Orphan designation - Commission Decision (2018)5730 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/099/18

Europe -DG Health and Food Safety

6-8-2018

Cetrotide (Merck Europe B.V.)

Cetrotide (Merck Europe B.V.)

Cetrotide (Active substance: Cetrorelix (as acetate)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5373 of Mon, 06 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/233/T/67

Europe -DG Health and Food Safety