Class 2 Medicines Recall: Pharmaram Ltd, Clexane 4,000 IU (40mg)/0.4ml Syringes, EL (20)A/37

Pharmaram Ltd has informed us that a specific batch of Clexane 4,000IU (40mg)/0.4ml syringes has an error on the labelling affixed to the plastic blister packaging encasing the syringe.

From:
Medicines and Healthcare products Regulatory Agency
Published
4 August 2020
Message type:
Medicines recall/notification
Medical specialty:
Pharmacy
Issued:
4 August 2020

PL Number

PLPI 33652/0067

MDR Number

MDR 229-07/20

Company Name

Pharmaram Ltd

Product description

Clexane 4,000 IU (40mg)/0.4ml Syringes

  • Batch Number: CCL67G/D3
  • Expiry Date: 31 October 2022
  • Pack Size: 10 syringes per pack
  • First Distributed: 16 July 2020

Active pharmaceutical ingredient: Enoxaparin sodium

Brief description of the problem

Pharmaram Ltd has informed us that a specific batch of Clexane 4,000IU (40mg)/0.4ml syringes has an error on the labelling affixed to the plastic blister packaging encasing the syringe. The label incorrectly 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; the batch number and expiry dates are also correct and match the details on the labelling.

Advice for healthcare professionals

  • Stop supplying the above products immediately and remove from the shelves within your pharmacy/store. Quarantine all remaining stock and return these to your supplier using your supplier’s approved process.
  • Patients who have been supplied this batch of Clexane 4,000IU (40mg)/0.4ml Syringes should be informed that the error is only with the labelling on the plastic blister packaging encasing the syringe.

Further Information

For Stock control enquiries please contact:

Pharmaram Ltd Austin Chambers Email: austin@dixpharm.com

Tel: +44 (0) 1530 410920

Mob: +44 (0) 7944 664400

For any medical information enquiries please contact:

Pharmaram Ltd

Email: quality@dixpharm.com

Tel: +44 (0) 1530 410920

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter.

NHS England and NHS Improvement Regional Offices are asked to forward this alert to community pharmacy contractors.

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Class 2 Medicines Recall: Pharmaram Ltd, Clexane 4,000 IU (40mg)/0.4ml Syringes, EL (20)A/37

Updates to this page

Published 4 August 2020
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