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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

27.04.2017

Rapid Alert Notification of a Quality Defect/Recall: RAS-I-Meldung

Rapid Alert Notification of a Quality Defect / Recall

RAS-I-Meldung –
Rückruf Albiomin / Human Albumin Biotest

Product Recall Class of Defect:
I

Falsification / Fraud (specify)*
N. A.

Product:

Albiomin / Human Albumin Biotest

Marketing Authorisation Number:

5% (50 g/l): PEI.H.03575.01.1
20 % (200 g/l): PEI.H.03574.01.1

Brand/Trade Name:
See tabulated listing provided by manufacturer/MAH

INN or Generic Name:

Human plasma protein with not less than 96% human albumin

Dosage Form:
Solution for infusion

Strength:

50 g/l (5 %) and 200 g/l (20 %)

Batch/Lot Number:
Batch number (and bulk, if different):
See tabulated listing provided by manufacturer/MAH

Expiry Date:
See tabulated listing provided by manufacturer/MAH

Pack size and Presentation:
50 g/l: Vial with 250 ml
200 g/l: Vial with 50 ml and 100 ml

Date Manufactured:

*See tabulated listing provided by manufacturer/MAH
Marketing Authorisation Holder:
Marketing Authorisation Holder: *Biotest Pharma GmbH (Germany) –
For other countries: see tabulated listing provided by manufacturer/MAH for other countries.

Contract Manufacturer:
 

Contact Person:
Qualified Person: Dr. Volker Wippersteg +49 1522 2801301
QP Phramacovigilance: Dr. Rainer Schmeidl +49 176 10047011

Recalling Firm (if different):

N. A.

Recall Number Assigned (if available): 
N. A.

Details of Defect/Reason for Recall:

Leakage in sterile Vessel. contamination, with cooling liquid predominantly ethylene glycol and trace amounts of additives such as anti-corrosives and dyes. Sterility is apparently not compromised. In the empty and cleaned tempering vessel for the final intermediate of human Albumin a hairline crack was identified being the root cause of contamination (also see in the appendix).

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

*Tabulated Listing

Action taken by Issuing Authority:

Withdrawal of batch release: concerned batches with national and EU-certificate

Proposed Action:

Recall at pharmacies and clinical level MAH Biotest committed to voluntarily recall the affected batches (please refer to attached list of batches)

From:

Paul-Ehrlich-Institut, federal Institut

Contact Person:

Dr. Susanne Müller

Telephone:
+49 6103 773116

Date:

25.04.2017

Time:

2 pm

Tabelle:
Mit Bescheid vom 25.04.2017 zurückgenommene Chargenfreigaben der Arzneimittel Albiomin 5% und  Albiomin 20 %

Arzneimittelname     Volumen        Ch.-Bez.     Freigabedatum         Verfallsdatum
Albiomin 5 %              250 ml           B231016       02.03.16                     31.12.18  
Albiomin 5 %              250 ml           B231026       24.02.16                     31.12.18
Albiomin 5 %              250 ml           B231086       22.08.16                     28.02.19
Albiomin 5 %              250 ml           B231176       04.10.16                     31.03.19
Albiomin 5 %              250 ml           B231264       06.11.14                     31.08.17
Albiomin 5 %              250 ml           B231294       06.11.14                     31.08.17
Albiomin 5 %              250 ml           B231295       10.09.15                     30.06.18
Albiomin 5 %              250 ml           B231325       06.10.15                     31.07.18
Albiomin 5 %              250 ml           B231326       02.12.16                     30.09.19
Albiomin 5 %              250 ml           B231345       06.10.15                     31.07.18
Albiomin 5 %              250 ml           B231364       06.01.15                     31.10.17
Albiomin 5 %              250 ml           B231386       06.01.17                     31.10.19
Albiomin 20%               50 ml           B234055       04.03.15                     31.12.17
Albiomin 20%               50 ml           B234286       11.05.16                     31.01.19
Albiomin 20%               50 ml           B234304       11.06.14                     31.03.17
Albiomin 20%               50 ml           B234404       18.07.14                     31.03.17
Albiomin 20%               50 ml           B234535       22.06.15                     31.03.18
Albiomin 20%               50 ml           B234665       23.07.15                     30.04.18
Albiomin 20%               50 ml           B234986       05.08.16                     31.05.19
Albiomin 20%               50 ml           B235024       10.10.14                     31.07.17
Albiomin 20%               50 ml           B235394       14.01.15                     30.09.17
Albiomin 20%             100 ml           B236045       01.04.15                     31.01.18
Albiomin 20%             100 ml           B236085       17.04.15                     28.02.18
Albiomin 20%             100 ml           B236165       30.04.15                     28.02.18
Albiomin 20%             100 ml           B236186       30.06.16                     30.04.19
Albiomin 20%             100 ml           B236275       17.07.15                     30.04.18
Albiomin 20%             100 ml           B236286       10.08.16                     31.05.19
Albiomin 20%             100 ml           B236314       11.09.14                     31.05.17
Albiomin 20%             100 ml           B236335       14.09.15                     31.05.18
Albiomin 20%             100 ml           B236366       28.10.16                     31.08.19
Albiomin 20%             100 ml           B236384       19.09.14                     30.06.17
Albiomin 20%             100 ml           B236425       09.10.15                     31.07.18
Albiomin 20%             100 ml           B236454       21.10.14                     31.07.17
Albiomin 20%             100 ml           B236465       11.11.15                     31.08.18
Albiomin 20%             100 ml           B236486       09.01.17                     31.10.19
Albiomin 20%             100 ml           B236505       14.01.16                     30.09.18
Albiomin 20%             100 ml           B236635       15.02.16                     31.10.18
Albiomin 20%             100 ml           B236684       09.01.15                     31.10.17
Albiomin 20%             100 ml           B236704       28.01.15                     31.10.17
Albiomin 20%             100 ml           B236724       06.02.15                     30.11.17



 

 

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05.04.2017

Rapid Alert Notification of a Quality Defect/Recall: RAS-II-Meldung

Rapid Alert Notification of a Quality Defect / Recall
RAS-II-Meldung –
Rückruf EpiPen und EpiPen Junior
(Fastjekt® Junior, Fastjekt® Epipen® Junior (Slovenia))

Product Recall Class of Defect:
II

Falsification / Fraud (specify)*
N.A.

Product:
Fastjekt® Junior, Fastjekt® Epipen® Junior (Slovenia)

Marketing Authorisation Number:
For use in humans: Fastjekt Junior: 65312.00.00
For use in humans: Fastjekt: 13579.00.00

Brand/Trade Name:
Fastjekt Junior, Fastjekt Junior N2 (Doppelpack), Fastjekt, Epipen® Junior (Slovenia)

INN or Generic Name:
Epinephrine

Dosage Form:
Solution for injection Autoinjektor (Pen)

Strength:
0,15 mg (Fastjekt Junior) 0,3 mg (Fastjekt)

Batch/Lot Number:
Germany:
Fastjekt®: 6FA292E
Fastjekt® Junior: 5ED824K, 5ED824J, 5ED824W, 5ED824AT, 6ED117D

Slovenia:
Epipen Junior® 6ED117H

Expiry Date:
Fastjekt® Junior: 5ED824K, 5ED824J, 5ED824W, 5ED824AT/ 05-2017
Fastjekt Junior (DE): 6ED117D/ 09-2017
Epipen Junior (SL): 6ED117H / 09-2017
Fastjekt: 6FA292E / 11-2017

Pack size and Presentation:
1 Pen for injection resp. 2 Pens for Injection (Fastjekt® Junior N2 Doppelpack)

Date Manufactured:
Fastjekt® Junior: 5ED824K 02.03.2016
Fastjekt® Junior: 5ED824J 04.02.2016
Fastjekt® Junior: 5ED824W 26.02.2016
Fastjekt® Junior: 5ED824AT 05.04.2016
Fastjekt Junior (DE): 6ED117D 28.06.2016
Epipen Junior (SL): 6ED117H 27.06.2016
Fastjekt: 6FA292E 03.06.2016

Marketing Authorisation Holder:
*: Meda Pharma GmbH & Co. KG

Contract Manufacturer:
Meda Pharma GmbH & Co. KG,
Benzstr. 1, 61352 Bad Homburg
Contact Person: Dr. Dietmar Hofmann
Telephone: +49 6172 8882301

Recalling Firm (if different):
N. A.

Recall Number Assigned (if available): 
DE_HE_148_2017

Details of Defect/Reason for Recall:
Two incidents of failure to activate the medicinal product.
The failure to activate is the result of a defective outer tube lot (also look in the appendix).

Information on distribution including exports (type of customer, e. g. hospitals):*
The batches have been distributed to German wholesalers and pharmacies. Parts of the batches have also been released to other European markets. Meda Pharma GmbH & Co. KG is also the releasing site for markets in other European member states but holds the marketing authorization for Slovenia and Germany only. According to Meda all authorities in member states where the batches were distributed have been informed about the recall. In other European countries, the product is being marketed under the name Epipen.

Action taken by Issuing Authority:
Monitoring of recall in marktes where Meda Pharma GmbH & Co. KG holds the MA. Coordination with Slovenian Health authority.

Proposed Action:
In addition to the recall from pharmacies and wohlesalers Meda will inform prescribing physicians and pharmacies by a DHCP letter. HCPs are asked to contact and inform patients who received a prescription for Fastjekt or Fastjekt junior during the distribution period.

From:
Regierungspräsidium Darmstadt
Mail to: pharmazie@rpda.hessen.de

Contact Person:
Dr. Christopher Kurz

Telephone:
+49 6151 12-5797

Date:
04.04.2017

Time:
16.45

 

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