Class 2 Medicines Recall, medac GmbH (T/A medac Pharma LLP) Sodiofolin 50mg/ml Solution for Injection 100mg/2ml, PL 11587/0005, EL (20) A/61
Medac Pharma LLP is recalling specific batches of products due to some inspected vials showing hairline damage to the shoulder of the vials. This is a second alert for further batches identified.
Product information
PL Number
PL 11587/0005
MDR Number
MDR 038-11/20
Company name
medac GmbH T/A medac Pharma LLP
Product description
Sodiofolin 50mg/ml Solution for Injection 100mg/2ml
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| L180633D | 31/10/2021 | 1 x 1 | 05/06/2019 |
| L180633L | 31/10/2021 | 1 x 1 | 08/10/2019 |
| L180633P | 31/10/2021 | 1 x 1 | 09/02/2020 |
| M190771B | 30/11/2022 | 1 x 1 | 08/11/2020 |
Active Pharmaceutical Ingredient: disodium folinate
Brief description of the problem
Further to Drug Alert EL (20)A/52 issued on 11 November 2020, medac Pharma LLP is recalling further batches of products following inspection of vials showing hairline damage to the shoulder of the vials. So far, the company has not received any reports of damage for marketed products. However, as this defect may impact on the sterility of the product, the above batches are being recalled as a precautionary measure.
Advice for healthcare professionals
Stop supplying the batch above immediately. Quarantine all stock and return it to your supplier using your supplier’s approved process.
Further Information
For more information or medical information queries, please contact [email protected] or telephone 01786 458086.
Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
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