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Class 3 Drug Alert (Action Within 5 Days): Marlborough Pharmaceuticals Ltd - Gygel Contraceptive Jelly - Nonoxinol-9 - EL (13)A/03

Document details:

Type: Drug Alert
Series No: EL (13)A/03
Audience: Healthcare professionals
Published: 29 January 2013
Format: Electronic only
Size: A4
Pages: 1
Price: Free
ISBN/ISSN:
Author:
Copyright: Crown
   

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DRUG ALERT

CLASS 3 MEDICINES RECALL

Action Within 5 Days


PHARMACY LEVEL RECALL

29 January 2013 EL (13)A/03 Our ref: 

MDR  53-01/13


Dear Healthcare Professional,

Marlborough Pharmaceuticals Ltd

Gygel Contraceptive Jelly

Nonoxinol-9

PL 23138/0010


Batch number Expiry date Pack size First distributed
1135170 June 2013 30g 31 March 2012

Marlborough Pharmaceuticals Ltd is recalling the above batch as a precaution because the results of assays carried out on one of the preservatives during routine stability studies did not comply with the required specification. Preservative efficacy tests carried out on this batch at the same time point complied with the Ph. Eur. specification so this finding is not expected to pose a risk to patient safety.

Remaining stocks of the affected batches should be quarantined and returned to the original supplier for credit. For enquiries relating to stock returns please contact UDG Credit Claims at udgcreditclaims@udg.co.uk

For medical information enquiries please contact 01748 828 789 (24 hour).

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. Primary care trusts are asked to forward this to relevant clinics and to general practitioners and community pharmacists for information.

Yours faithfully

Alison Bunce
Pharmaceutical Assessor, DMRC

MHRA Distribution (further recipients by cascade): Regional Contacts for NHS Trusts and provider units
Chief Pharmacists: England, Scotland, Wales, Northern Ireland
Prison health policy unit (DH)
Chief Pharmacists:  Jersey, Guernsey, Alderney, Sark, Isle of Man, Gibraltar
Special hospitals
Healthcare Commission for distribution to Independent health care establishments
Primary care trusts (England)
Page last modified: 29 January 2013