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)
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 5002058 | June 2022 | 10 x 5ml amps | 12 November 2019 |
Active Pharmaceutical Ingredient: Heparin Sodium (Porcine)
Brief description of the 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 for healthcare professionals
Stop supplying the above batch immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
Further Information
For more information or medical information queries, please contact:
For stock control queries, please contact:
customer.services@wockhardt.co.uk
Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
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