Class 4 Medicines Defect Information: Antibiotice SA, Piperacillin / Tazobactam 4g/0.5 g, powder for solution for infusion, EL (22)A/03
Class 4 Medicines Defect Information: Antibiotice SA, Piperacillin / Tazobactam 4g/0.5 g, powder for solution for infusion, EL (22)A/03
Antibiotice SA have identified an error on PIL of the above batches regarding the sodium content.
MDR Number: MDR 046-01/22
Company name: Antibiotice SA
Product description: Piperacillin/Tazobactam 4 g/0.5g Powder for solution for infusion PL 16329/0002
Details of the affected batches:
|
Batch Number |
Expiry Date |
Pack Size |
First Distributed |
|
P3430007 |
10.2023 |
Box x 10 vials |
Not distributed yet |
|
P3430009 |
10.2024 |
Box x 10 vials |
Not distributed yet |
|
P3430010 |
10.2024 |
Box x 10 vials |
Not distributed yet |
|
P3430011 |
10.2024 |
Box x 10 vials |
Not distributed yet |
|
P3430012 |
10.2024 |
Box x 10 vials |
Not distributed yet |
|
P3430013 |
10.2024 |
Box x 10 vials |
Not distributed yet |
Brief description of problem:
Antibiotice SA have identified an error on PIL of the above batches regarding the sodium content. The correct content of sodium is presented in the following table:
|
Product |
Marketing Authorization (MA) |
Current PIL text (incorrect) |
Required PIL text acc. to MA (correct) |
|
Piperacillin / Tazobactam 4g/0.5 g, powder for solution for infusion |
PL 16329/0002 |
Piperacillin/Tazobactam contains sodium. Piperacillin/Tazobactam 4 g/0.5 g contains approximatively 9.39 mmol (108 mg) of sodium |
Piperacillin/Tazobactam contains sodium. Piperacillin/Tazobactam 4 g/0.5 g contains approximatively 9.39 mmol (216 mg) of sodium |
The PIL have correct information for sodium content expressed in mmol (9.39 mmol), but wrong sodium content expressed in mg (108 mg, instead of 216 mg). The correct sodium content is also stated in the SPC (9.39 mmol, respectively 216 mg of sodium).
Advice to Healthcare Professionals:
The impacted batches of Piperacillin/Tazobactam 4g/0.5 g, powder for solution for infusion product is within specification and there is no issue with product quality. The product is supplied as part of an NHS tender and the affected batches are not being recalled.
Since all batches are within specification and there are no quality issues with the product, the batches on hold awaiting distribution will be sold and have been included in this notification for information. The batches have been approved by the MHRA.
Healthcare professionals are advised to calculate the sodium content (for patients with sodium restricted diet) when administering this product using the value of 9.39 mmol (corresponding to 216 mg) of sodium for the product Piperacillin / Tazobactam 4 g/0.5 g powder for solution for infusion.
Antibiotice SA have confirmed that all future batches will contain the correct PIL in compliance with approved Marketing Authorisation.
Company contacts for further information:
For medical information please contact: medical@antibiotice.ro
For stock control queries please contact: shaunak@esteve.com, johnson@esteve.com or dromard@esteve.com
To access the full recall: Class 4 Medicines Defect Information: Antibiotice SA, Piperacillin / Tazobactam 4g/0.5 g, powder for solution for infusion, EL (22)A/03