Class 4 Medicines Defect Information: Piperacillin / Tazobactam 4g/0.5 g, powder for solution for infusion (Antibiotice SA)

Class 4 Medicines Defect Information: Piperacillin / Tazobactam 4g/0.5 g, powder for solution for infusion (Antibiotice SA)

Drug alert number: EL (22)A/03

Date issued: 31 January 2022

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for:

Class 4 Medicines Defect Information: Piperacillin / Tazobactam 4g/0.5 g, powder for solution for infusion (Antibiotice SA)

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 batches listed above 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.

View full alert here

Further Information

For medical information please contact:

medical@antibiotice.ro

For stock control queries please contact:

shaunak@esteve.com

johnson@esteve.com

dromard@esteve.com

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