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
| 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 |
| P3430014 | 10.2024 | Box x 10 vials | Not distributed yet |
| P3430015 | 10.2024 | Box x 10 vials | Not distributed yet |
Active Pharmaceutical Ingredients: Piperacillin (as sodium salt) and Tazobactam (as sodium salt).
Brief description of the 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 for 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.
Further Information
For medical information please contact:
For stock control queries please contact:
Recipients of this Medicines Notification 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.
Yours faithfully
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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