Gygel Contraceptive Jelly – test results did not comply with required specifaction
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| Type | Medicines recall/notification |
|---|---|
| Issued | 29 Jan 2013 |
| Reference | EL (13)A/03 |
| Product licences | PL 23138/0010 |
29 January 2013
Class 3 medicines recall
Action within 5 days
Pharmacy-level recall
MDR 53-01/13
Product details
Marlborough Pharmaceuticals Ltd
Gygel Contraceptive Jelly
Nonoxinol-9
PL 23138/0010
Alert details
- Batch number: 1135170
- Expiry date: June 2013
- Pack size: 30g
- First distributed: 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.
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)