Brochlor 1% w/w Eye Ointment – issue with seal integrity and compromised sterility assurance
- Medicines and Healthcare products Regulatory Agency
- 27 February 2013
- Alert type:
- Drug alert
(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
Brochlor 1% w/w Eye Ointment
|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 firstname.lastname@example.org.
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.
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
Healthcare Commission for distribution to Independent health care establishments
Primary care trusts (England)
Issued: 27 February 2013
Alert type: Drug alert