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Class 2 recall for Clexane 4,000 IU (40mg)/0.4ml

Labelling error affects one batch

August 4th 2020

Tagged: MHRA alert

By Charles Gladwin

Pharmaram Ltd is recalling a batch of Clexane 4,000 (40mg)/0.4ml Syringes (enoxaparin sodium) due to a labelling error.

The inner label, on the blister packaging encasing the syringe states “Clexane 6,000IU (60mg)/0.6ml Syringes”, when it should have stated “Clexane 4,000IU (40mg)/0.4ml Syringes”. The outer carton states the correct strength and the batch number and expiry dates are also correct and match the details on the labelling.

The Class 2 recall affects the following batch:

Batch NumberExpiry DatePack SizeFirst Distributed
CCL67G/D331 October 202210 syringes per pack16 July 2020

 

Dispensaries are asked to stop supplying this batch immediately and quarantine the product for return to the supplier.

Patients who have received this batch of Clexane 4,000IU (40mg)/0.4ml Syringes should be advised that the error is only with the labelling on the plastic blister packaging encasing the syringe.

For stock control enquiries contact Austin Chambers at Pharmaram Ltd via:

  • Tel: +44 (0) 1530 410920
  • Email: austin@dixpharm.com

For medical information enquiries contact Pharmaram Ltd via:

  • Tel: +44 (0) 1530 410920
  • Email: quality@dixpharm.com