Class 4 Medicines Defect Information: Phenobarbital Sodium 30mg/ml Injection (MDR 48-02/19)
Martindale Pharma has informed the Medicines and Healthcare products Regulatory Agency (MHRA) that the EAN bar code for the following batches is incorrect.
MDR Number
MDR 48-02/19
Company name
Martindale Pharma
Product description
Phenobarbital Sodium 30mg/ml Injection
PL 01883/6188R
| Batch number | Expiry Date | Pack size | First distributed |
|---|---|---|---|
| 0101620 | 10/2020 | 1 x 10 | 21/12/2018 |
| 0102721 | 11/2020 | 1 x 10 | 31/01/2019 |
| 0104613 | 11/2020 | 1 x 10 | 05/03/2019 |
| 0104155 | 10/2020 | 1 x 10 | 07/01/2019 |
Brief description of the problem
Martindale Pharma has informed MHRA that the EAN bar code on the above batches is incorrect. The barcode reference should have been 5014124170278 however code 501412470261 was applied to the carton in error. The incorrect barcode scans the batch as Phenobarbital Sodium Injection 200mg/ml.
All other information on the carton and ampoule label is correct for the above batches of Phenobarbital Sodium 30mg/ml Solution for Injection.
The barcode error increases the risk of product mix up when an automated inventory system is used to dispense the affected batch within the pharmacy or wholesale facility.
Advice for pharmacists
The barcode should not be used for any dispensing activities for this batch. Please bring this notice to the attention of all relevant staff within your facility.
If you have supplied units from this batch to any other pharmacy or clinic, please forward a copy of this Alert to them.
Advice for wholesalers
The barcode should not be used for wholesaling activities for this batch. Please bring this notice to the attention of all relevant staff within your facility.
If you have supplied units from this batch to any other wholesalers, please forward a copy of this Alert to them.
Contact details for further information
For any enquiries please contact Nick Flynn, Tel: 01708 336 412
Additional information
Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter.
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