Company led medicines recall: Bucain Hyperbar 5mg/ml Solution for Injection (unlicensed medicine), CLMR (22)A/01
Mawdsley-Brooks & Company Limited (UK importer) is recalling a specific batch of this product as a precautionary measure due out of specification result for pH that was identified during routine stability testing.
CLMR Number
CLMR (22)A/01
MDR Number
MDR 017-02/22
Company name
Mawdsley-Brooks & Company Limited
Product description
Bucain Hyperbar 5mg/ml Solution for Injection (unlicensed medicine)
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 80516A-1 | 30/04/2022 | 5 x 4ml | 26/07/2019 |
Active Pharmaceutical Ingredient: bupivacaine hydrochloride
Brief description of the problem
Mawdsley-Brooks & Company Limited (UK importer) is recalling the above batch as a precautionary measure due out of specification result for pH that was identified during routine stability testing.
This product is supplied to hospital pharmacies only.
This recall is being issued as a company-led recall due to the limited number of packs distributed, and the UK importer has full traceability of the product’s onward distribution.
Remaining stock of the above batch should be quarantined and returned to the UK importer directly.
Company contact for enquiries
For more information please contact Charlotte Ray: charlotte.ray@mawdsleys.co.uk.
Tel: 07342 949 102.