Many addictive drugs lacked statutory packaging seal

08 June 2015

Our laboratory contacted 35 companies in the period from December 2014 to April 2015. The purpose was to examine whether the companies had made sure to seal their packages with addictive drugs (cf. section 14 of Executive order no. 849 of 25 June 2013 on the labelling etc. of medicinal products).

17 companies did not comply with the rule

We found one or more medicine packages without a seal in 17 of the 35 companies. The 17 companies are now taking action to ensure that their packages are sealed as soon as possible. By the end of 2015, all new productions of these medicine packages will be sealed in accordance with Danish regulatory requirements. However, for a period of time packages without seals may be available in the market until all packages from previous productions have been sold.

List of medicinal products without a seal at the time of investigation:

Medicinal product name

Pharmaceutical form

Strength

Marketing authorisation holder

Concerta

prolonged-release tablets

18 mg

Janssen-Cilag A/S

Concerta

prolonged-release tablets

36 mg

Janssen-Cilag A/S

Concerta

prolonged-release tablets

54 mg

Janssen-Cilag A/S

Jurnista

prolonged-release tablets

8 mg

Janssen-Cilag A/S

Jurnista

prolonged-release tablets

16 mg

Janssen-Cilag A/S

Jurnista

prolonged-release tablets

32 mg

Janssen-Cilag A/S

S-ketamin "Pfizer"

solution for injection

5 mg/ml

Pfizer ApS

S-ketamin "Pfizer"

solution for injection

25 mg/ml

Pfizer ApS

Ketador Vet.

solution for injection

100 mg/ml

Richter Pharma AG (Danish representative Salfarm Danmark A/S)

Oxycodone hydrochloride "Orion"

solution for injection/infusion

10 mg/ml

Orion Corporation Orion Pharma (Danish representative Orion Pharma A/S)

Medikinet

tablets

5 mg

MEDICE Arzneimittel Pütter GmbH & Co. KG

Medikinet

tablets

10 mg

MEDICE Arzneimittel Pütter GmbH & Co. KG

Medikinet

tablets

20 mg

MEDICE Arzneimittel Pütter GmbH & Co. KG

Medikinet CR

modified-release capsules, hard

10 mg

MEDICE Arzneimittel Pütter GmbH & Co. KG

Medikinet CR

modified-release capsules, hard

20 mg

MEDICE Arzneimittel Pütter GmbH & Co. KG

Medikinet CR

modified-release capsules, hard

30 mg

MEDICE Arzneimittel Pütter GmbH & Co. KG

Medikinet CR

modified-release capsules, hard

40 mg

MEDICE Arzneimittel Pütter GmbH & Co. KG

Medikinet CR

modified-release capsules, hard

5 mg

MEDICE Arzneimittel Pütter GmbH & Co. KG

Medikinet CR

modified-release capsules, hard

50 mg

MEDICE Arzneimittel Pütter GmbH & Co. KG

Medikinet CR

modified-release capsules, hard

60 mg

MEDICE Arzneimittel Pütter GmbH & Co. KG

Oxycodone hydrochloride "Actavis"

capsules, hard

5 mg

Actavis Group PTC ehf. (Danish representative Actavis A/S)

Oxycodone hydrochloride "Actavis"

capsules, hard

10 mg

Actavis Group PTC ehf. (Danish representative Actavis A/S)

Oxycodone hydrochloride "Actavis"

capsules, hard

20 mg

Actavis Group PTC ehf. (Danish representative Actavis A/S)

Reltebon Depot

prolonged-release tablets

5 mg

Actavis Group PTC ehf. (Danish representative Actavis A/S)

Reltebon Depot

prolonged-release tablets

10 mg

Actavis Group PTC ehf. (Danish representative Actavis A/S)

Reltebon Depot

prolonged-release tablets

20 mg

Actavis Group PTC ehf. (Danish representative Actavis A/S)

Reltebon Depot

prolonged-release tablets

40 mg

Actavis Group PTC ehf. (Danish representative Actavis A/S)

Malfin

prolonged-release tablets

10 mg

Teva Denmark A/S

Malfin

prolonged-release tablets

30 mg

Teva Denmark A/S

Malfin

prolonged-release tablets

60 mg

Teva Denmark A/S

Malfin

prolonged-release tablets

100 mg

Teva Denmark A/S

Malfin

prolonged-release tablets

200 mg

Teva Denmark A/S

Methylphenidat "Orifarm"

tablets

10 mg

Orifarm Generics A/S

Oxycodone "Orifarm"

prolonged-release tablets

5 mg

Orifarm Generics A/S

Oxycodone "Orifarm"

prolonged-release tablets

10 mg

Orifarm Generics A/S

Oxycodone "Orifarm"

prolonged-release tablets

40 mg

Orifarm Generics A/S

Oxycodone "Orifarm"

prolonged-release tablets

80 mg

Orifarm Generics A/S

Anesketin

solution for injection

100 mg/ml

Eurovet Animal Health B.V. (Danish representative Dechra Veterinary Products A/S)

Comfortan Vet.

solution for injection

10 mg/ml

Eurovet Animal Health B.V. (Danish representative Dechra Veterinary Products A/S)

Fentadon Vet.

solution for injection

50 microgram/ml

Eurovet Animal Health B.V. (Danish representative Dechra Veterinary Products A/S)

Medicebran

tablets

20 mg

2care4 ApS

Ritalin LA

modified-release capsules, hard

10 mg

2care4 ApS

Ritalin LA

modified-release capsules, hard

20 mg

2care4 ApS

Ritalin LA

modified-release capsules, hard

30 mg

2care4 ApS

Ritalin LA

modified-release capsules, hard

40 mg

2care4 ApS

Equasym Depot

modified-release capsules, hard

10 mg

Shire Pharmaceuticals  Ireland L

Equasym Depot

modified-release capsules, hard

20 mg

Shire Pharmaceuticals  Ireland L

Equasym Depot

modified-release capsules, hard

30 mg

Shire Pharmaceuticals  Ireland L

Palexia

film-coated tablets

50 mg

Grünenthal GmbH (Danish representative Grünenthal Denmark ApS)

Palexia Depot

prolonged-release tablets

50 mg

Grünenthal GmbH (Danish representative Grünenthal Denmark ApS)

Palexia Depot

prolonged-release tablets

100 mg

Grünenthal GmbH (Danish representative Grünenthal Denmark ApS)

Palexia Depot

prolonged-release tablets

150 mg

Grünenthal GmbH (Danish representative Grünenthal Denmark ApS)

Palexia Depot

prolonged-release tablets

200 mg

Grünenthal GmbH (Danish representative Grünenthal Denmark ApS)

Palexia Depot

prolonged-release tablets

250 mg

Grünenthal GmbH (Danish representative Grünenthal Denmark ApS)

Recivit

sublingual tablets

67 microgram

Grünenthal Denmark ApS

Recivit

sublingual tablets

133 microgram

Grünenthal Denmark ApS

Recivit

sublingual tablets

267 microgram

Grünenthal Denmark ApS

Recivit

sublingual tablets

400 microgram

Grünenthal Denmark ApS

Recivit

sublingual tablets

533 microgram

Grünenthal Denmark ApS

Recivit

sublingual tablets

800 microgram

Grünenthal Denmark ApS

Metadon "Evolan"

oral solution

1 mg/ml

Evolan Pharma AB (Danish representative Matrix Pharmaceuticals A/S)

Medicebran

tablets

20 mg

EuroPharma.DK ApS

Medikinet CR

modified-release capsules, hard

10 mg

EuroPharma.DK ApS

Medikinet CR

modified-release capsules, hard

20 mg

EuroPharma.DK ApS

Medikinet CR

modified-release capsules, hard

30 mg

EuroPharma.DK ApS

Medikinet CR

modified-release capsules, hard

40 mg

EuroPharma.DK ApS

Ketaminol Vet.

solution for injection

50 mg/ml

Intervet International B.V. (Danish representative Intervet Danmark A/S)

Ketaminol Vet.

solution for injection

100 mg/ml

Intervet International B.V. (Danish representative Intervet Danmark A/S)

Oramorph

oral drops, solution

20 mg/ml

L. Molteni & C. dei F.lli Alitti Societa di Esercizio S.p.A. (Danish representative Tabs n Caps Pack ApS)

Oramorph

oral solution

2 mg/ml

L. Molteni & C. dei F.lli Alitti Societa di Esercizio S.p.A. (Danish representative Tabs n Caps Pack ApS)

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