Class 2 Medicines Recall: Wockhardt UK Ltd, Heparin sodium 1,000 I.U./ml solution for injection or concentrate for solution for infusion, EL (21)A/38

One batch is being recalled due to out of specification results due to a low bioassay result at the 24-month shelf life stability testing.

MDR Number: MDR 166-12/21

Company name: Wockhardt UK Ltd

Product description: Heparin sodium 1,000 I.U./ml solution for injection or concentrate for solution for infusion (preservative free) (PL 29831/0105)

Details of the affected batch:

Brief description of problem:

Wockhardt UK Ltd is recalling the above batch as a precautionary measure due to out of specification results due to a low bioassay result at the 24-month shelf life stability testing.

Advice to Healthcare Professionals:

Stop supplying the above batch immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process

Company contacts for further information:

For more information or medical information queries, please contact:

drug.safety@wockhardt.co.uk

For stock control queries, please contact:

customer.services@wockhardt.co.uk

To access the full recall: Class 2 Medicines Recall: Wockhardt UK ltd, Heparin sodium 1,000 I.U./ml solution for injection or concentrate for solution for infusion, EL (21)A/38