Class 4

Class 4 Medicines Defect Information: Fresenius Kabi Limited, Sodium Chloride 0.% Intravenous Infusion BP (Freeflex and Freeflex Plus), EL (24)A/17

Added

Author

Cathy

Categories

Fresenius Kabi Limited have informed the MHRA of a packaging error with specific batches of Sodium Chloride Intravenous Infusion 0.9% Freeflex and Freeflex PLUS.

MDR Number: MDR 035-05/24

Company name: Fresenius Kabi Limited

Product descriptions: 

Sodium Chloride 0.9% Intravenous Infusion BP [Freeflex], PL 08828/0084 SNOMED Code 40546011000001103

Batch NumberExpiry DatePack SizeFirst DistributedError type
13SKL10130/09/202620 x 500 ml23/01/2024No PIL in the box
13TAL21331/12/202620 x 500 ml06/03/2024No PIL in the box

 

Sodium Chloride 0.9% Intravenous Infusion BP [Freeflex], PL 08828/0084 SNOMED Code 40545411000001103

Batch NumberExpiry DatePack SizeFirst DistributedError type
13SMF06130/11/202630 x 250 mlNot yet distributedNo PIL in the box
13TBF28131/01/202730 x 250 mlNot yet distributedNo PIL in the box

 

Sodium Chloride 0.9% Intravenous Infusion BP [Freeflex Plus], PL 08828/0084 SNOMED Code 42071711000001100

Batch NumberExpiry DatePack SizeFirst DistributedError type
13SLF24231/10/202550 x 100 ml17/01/2024Outdated PIL
13TAF17331/12/202550 x 100 ml29/03/2024Outdated PIL

 

Brief description of problem:

Fresenius Kabi Limited have informed the MHRA of a packaging error with specific batches of Sodium Chloride Intravenous Infusion 0.9% Freeflex and Freeflex PLUS. Some batches were packaged without the patient information leaflet (PIL), and some were packaged with an older version of the PIL.

Although two of batches that have been packaged without a PIL have not yet been distributed, due to the consideration of supply and that Fresenius Kabi Limited will be providing printed copies of the correct PIL, these batches will not be repackaged and will continue to be distributed. 

The current approved version of the PIL contains an additional product name (Freeflex ProDapt) and a 2D data matrix. Freeflex ProDapt is not marketed in the UK, however a common PIL is used for the various presentations of the product. The 2D matrix contains information about the product batch number, expiry dates and the GTIN reference, which are also present in human readable format on the product.

The affected texts in the older PIL (revised 09/2016) and the updated texts in the current approved PIL (revised 01/2022) are detailed below:

Affected texts in older PILUpdated texts in current approval PIL

 

Product name:

Sodium Chloride 0.9% Intravenous Infusion BP as Steriflex No 1 or Freeflex or Freeflex Plus

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

 

Product name:

Sodium Chloride 0.9% Intravenous Infusion BP as Steriflex No 1 or Freeflex or Freeflex Plus or Freeflex ProDapt

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See Section 4

 

Section 4:

If the side effects gets serious please tell your doctor or pharmacist.

 

Section 4:

If the side effects gets serious please tell your doctor or pharmacist.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme website or search for MHRA Yellow Card in the Google Play or Apple App Store

By reporting side effects you can help provide more information on the safety of this medicine.

 

Section 6:

What Sodium Chloride 0.9% intravenous infusion looks like and contents of the pack. Sodium Chloride Intravenous Infusion BP is a clear solution of sodium chloride in water. The solution is contained in a sealed plastic container, known as a Steriflex® bag or freeflex bag, or freeflex bag.

 

Section 6:

What Sodium Chloride 0.9% intravenous infusion looks like and contents of the pack. Sodium Chloride Intravenous Infusion BP is a clear solution of sodium chloride in water. The solution is contained in a sealed plastic container, known as a Steriflex® bag or freeflex bag, or freeflex bag or freeflex ProDapt.

Advice to Healthcare Professionals:

This notification is intended to inform healthcare professionals of the discrepancy with the PIL for specific batches of product. There is no product quality nor patient safety-related implications with this issue.

Fresenius Kabi Limited have confirmed that printed copies of the correct PIL will accompany the future delivery/order of these batches.

The current approved PIL is also available on the MHRA website.

Advice to Patients:

The product quality and safety are not affected by this issue. Patients should continue using medicines from these batches as prescribed by your healthcare professional.

Patients who experience adverse reactions or have any questions about the medication, should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

Company contacts for further information:

For more information or medical information queries please email Medical.Information-UK@fresenius-kabi.com or telephone +44 (0) 1928 533575.

For stock control enquiries please contact FK.complaints-uk@fresenius-kabi.com or telephone +44 (0) 1928 533758.

To access the full recall: Class 4 Medicines Defect Information: Fresenius Kabi Limited, Sodium Chloride 0.9% Intravenous Infusion BP [Freeflex and Freeflex Plus], EL(24)A/17