Brochlor 1% w/w Eye Ointment – issue with seal integrity and compromised sterility assurance

(Sanofi-aventis) Remaining stocks of the affected batches should be quarantined and returned to the original supplier for credit – class 2 action within 48 hours. (EL (13)A/07)

27 February 2013

Class 2 medicines recall

Action within 48 hours

Pharmacy, wholesaler and clinic-level recall

MDR 56-02/13

Product details

Sanofi-aventis

Brochlor 1% w/w Eye Ointment

(Chloramphenicol)

PL 04425/0367

Alert details

Batch number   Expiry date   Pack size   First distributed
122702   31 December 2016   1 x 4g   1 February 2013
122727   31 December 2016   1 x 4g   12 February 2013

Sanofi-aventis are recalling all remaining stock of these batches to pharmacy, clinic and wholesaler level, due to an issue with seal integrity and compromised sterility assurance, introduced during the filling process.

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 Sanofi-aventis Customer Services on 0800 854430 or email GB-CustomerServices@sanofi.com.

For medical information enquiries please contact Sanofi-aventis Medical Information on 0845 3727101 or email uk-medicalinformation@sanofi.com.

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, general practitioners, optometrists 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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