Gygel Contraceptive Jelly – test results did not comply with required specifaction

(Merck Sharp & Dohme Ltd) Being recalled as a precaution because results of assays for routine stability studies did not comply with required specification class 3 action within 5 days. (EL (13)A/03)

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


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

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)

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Published 17 December 2014