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AMK Meldungen

Über den unten stehenden Link gelangen Sie auf die Internet-Seite der Pharmazeutischen Zeitung online (PZ online).

Die Meldungen der Arzneimittelkommission sind Fachinformationen, die nur bestimmten Berufsgruppen zur Verfügung gestellt werden können. Apotheker finden die notwendigen Zugangsdaten in jeder Druckausgabe der PZ online in der Rubrik AMK-Nachrichten.

  Meldungen der Arzneimittelkommission

AM-Rückruf Klasse 1

02.10.2017

Rapid Alert Notification of a Quality Defect / Recall

RAS-I-Meldung – Rückruf Injektionslösungen der Fa. Rotexmedica

Product Recall Class of Defect: 
I

Counterfeit / Fraud (specify)*
N/A

Product:
Hydrocortison 100 mg Rotexmedica
Marketing Authorisation Number:
Hydrocortison-100 Rotexmedica (DE):
6625007.00.00
(for use in humans)

Brand/Trade Name:
1) Hydrocortisone sodium succinate for injection USP
2) Hydrocortisone sodium succinate for injection USP
3) Hydrocortisone sodium succinate for injection USP
4) Hydrocortison-100 Rotexmedica

INN or Generic Name:
Hydrocortison 100 mg

Dosage Form:
Lyophilisate for solution for injection or Infusion

Strength:
100 mg

Batch/Lot Number:
1) 304404
2) 304405
3) 304472
4) 304473

Expiry Date:
1) 03/2020
2) 03/2020
3) 04/2020
4) 04/2020

Pack size and Presentation:
1) Pack of 100 x 8ml Vial
2) Pack of 100 x 8ml Vial
3) Pack of 100 x 8ml Vial
4) Pack of 1 x 8ml Vial

Date Manufactured:
1) 03/2017
2) 03/2017
3) 04/2017
4) 04/2017

Marketing Authorisation Holder: *
1) Rotexmedica/Germany for Jordan, Panpharma/France for Sudan (registration in process), LF Asia in HongKong, Rotexmedia/Germany for DURBIN (Wholesaler)
2) Panpharma/France for Sudan (registration in progress)
3) Panpharma/France for Sudan (registration in progress); Rotexmedica/Germany for Nigeria; Minapharm for Lebanon
4) Rotexmedica GmbH ARZNEIMITTELWERK / Germany

Manufacturer:
Panpharma SA
10 rue du Chenot
Parc d’activité du chenot
F-56380 Beignon
France

Recalling Firm:

Rotexmedica GmbH ARZNEIMITTELWERK
Bunsenstraße 4
22946 Trittau
Germany

All batches have been released / certified by
Rotexmedica GmbH ARZNEIMITTELWERK

Contact Person:
Freya Behrend

Telephone:
+49 (0) 4154 862 161

Recall Number Assigned (if available):
N/A

Details of Defect/Reason for Recall:
Due to a deviation at the glass vials’ manufacturer Bormioli, Italy vials marked with the mold number “uO” may have a defect at the bottles neck. The defect cannot be visually detected. The integrity of the vials with the mold number “uO” may be compromised due to the defect.

Information on distribution including exports (type of customer, e. g. hospitals):*
1) Batch 304404 (pack of 100):
Jordan: Rida Jardaneh Drug Store (RJDS)
P.O. Box 803, Amman 11118, Jordan
Sudan: NMSF (National Medical Supplies Fund)
P.O. Box 297, Khartoum, Sudan
HongKong: LF Asia (Hong Kong) Limited
5/F., DCH Building, 20 Kai Cheung Road, Kowloon Bay, Kowloon, Hong Kong
DURBIN: Durbin Plc.
19 Fairway Drive, UB6 8PW Greenford, Middlesex, UK

2) Batch 304405 (pack of 100):
Sudan: NMSF (National Medical Supplies Fund)
P.O. Box 297, Khartoum, Sudan

3) Batch 304472 (pack of 100):
Sudan: NMSF (National Medical Supplies Fund)
P.O. Box 297, Khartoum, Sudan
Lebanon: Pharmacie MINAPHARM Al-Halabi
Nakad building, Main road, Zahrieh area Tripoli (Tripoli) Lebanon
Nigeria: Alpha Pharmacy Ltd.
2B Alabi Street, Ikeja, Lagos, Nigeria

4) Batch 304473 (pack of 1):
Germany (Rotexmedica)

Action taken by Issuing Authority:
The recall of batch 304473 is under supervision of Landesamt für soziale Dienste Schleswig-Holstein.
Information of the competent authorities via RAN document.

Proposed Action:
Recall of the affected batch 304473 from the German market.
The company will contact the above listed customers in the affected countries directly.

From (Issuing Authority):
Landesamt für soziale Dienste Schleswig-Holstein
Abteilung 3 Gesundheits- und Verbraucherschutz
Arzneimittelüberwachung
Adolf-Westphal-Straße 4
24143 Kiel

Contact Person:

Telephone: +49 (0)431 988 5615
E-Mail: heike.carstensen@lasd.landsh.de

Signed:
Carstensen

Date:
28.09.2017

Time:
14:40


 

02.10.2017

Rapid Alert Notification of a Quality Defect / Recall

RAS-I-Meldung – Rückruf Injektionslösungen der Fa. Rotexmedica

Product Recall Class of Defect:
I

Counterfeit / Fraud (specify)*
N/A

Product:
ASL 900 mg

Marketing Authorisation Number:
N/A (no marketing authorisation in the EU)

Brand/Trade Name:
PAN – A.S.L. 900 mg

INN or Generic Name:

Acetylsalicylic acid Iysine + glycine

Dosage Form:

powder for solution for injection

Strength:

900 mg

Batch/Lot Number:

304445

Expiry Date:

03/2019

Pack size and Presentation:

100 vials á 8 ml

Date Manufactured:

03/2017

Marketing Authorisation Holder: *

N/A

Manufacturer:

Panpharma SA
10 rue du Chenot
Parc d’activité du chenot
F-56380 Beignon
France

Recalling Firm:

Rotexmedica GmbH
ARZNEIMITTELWERK
Bunsenstraße 4
22946 Trittau
Germany

Contact Person:

Freya Behrend

Telephone:

+49 (0) 4154 862 161

Recall Number Assigned (if available):

N/A

Details of Defect/Reason for Recall:

Due to a deviation at the glass vials’ manufacturer Bormioli, Italy vials marked with the mold number “uO” may have a defect at the bottles neck. The defect cannot be visually detected. The integrity of the vials with the mold number “uO” may be compromised due to the defect.

Information on distribution including exports (type of customer, e. g. hospitals):*

Rotexmedica distributed as a wholesaler 4500 units to German hospital pharmacies. The product was delivered acc. to article 73 para 3 German Drug Law to Germany to ensure the supply of the medicinal product to patients in the hospitals.

The batch was distributed by Panpharma also to Togo, Kamerun, Belgium and Portugal.

Action taken by Issuing Authority:

The company will contact the customers directly and recall vials with the mold number “uO” to continue to ensure the supply of patients with the emergency medicinal product. The recall of batch 304445 as described is under supervision of Landesamt für soziale Dienste Schleswig-Holstein.

Information of the ANSM via RAN document.

Proposed Action:

The company will contact the customers directly and recall vials with the mold number “uO” to continue to ensure the supply of patient with the medicinal product.

From (Issuing Authority):

Landesamt für soziale Dienste Schleswig-Holstein
Abteilung 3 Gesundheits- und Verbraucherschutz
Arzneimittelüberwachung
Adolf-Westphal-Straße 4
24143 Kiel

Contact Person:

Telephone: +49 (0)431 988 5615
E-Mail: heike.carstensen@lasd.landsh.de

Signed:

Carstensen

Date:

28.09.2017

Time:

15:00

 

 

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