Class 4

Class 4 Medicines Defect Information: Altan Pharma Limited, Phenylephrine 0.08 mg/ml - solution for injection/infusion, EL(22)A/29

Altan Pharma Limited have identified an error relating to the product packaging. The incorrect concentration of phenylephrine base is provided on the overwrapping bag label.

MDR Number: MDR 198-05/22

Company name: Altan Pharma Limited

Product description: Phenylephrine 0.08 mg/ml - solution for injection/infusion PL 46788/0024

Details of the affected batch:

Batch Number

Expiry Date

Pack Size

First Distributed

FE221001

05/2024

10 bags of 100ml

April 2022

Brief description of problem:

Altan Pharma Limited have identified an error relating to the product packaging. The incorrect concentration of phenylephrine base is provided on the overwrapping bag label.

  • The label states that: 1 ml contains 0.08 mg of phenylephrine base. Each bag of 100 ml contains 10 mg of phenylephrine base that corresponds to 10 mg of phenylephrine hydrochloride.
  • However, the correct label should state: 1 ml contains 0.08 mg of phenylephrine base. Each bag of 100 ml contains 8 mg of phenylephrine base that corresponds to 10 mg of phenylephrine hydrochloride.

Information on the product carton, bag label and SmPC remain correct, and this product is not being recalled.

Advice to Healthcare Professionals:

Healthcare professionals are advised to exercise caution when using the product and in relation to the impacted batch and should refer to the label dose on the actual bag which remains correct.

As stated above, each bag of 100 ml contains 8 mg of phenylephrine base that corresponds to 10 mg of phenylephrine hydrochloride and this information should be used when using this product during dispensing and administering (i.e., for dose adjustments). Healthcare professionals may wish to retain a copy of this notification, and Altan Pharma Limited have confirmed that they will be supplying this notification with each pack.

Advice to Patients:

Patients are not required to take any action at this time. This product is administered by healthcare professionals directly and the medicine itself is not affected. If you have concerns about a medicine you may be using, please contact your healthcare professional.

 

Company contacts for further information:

For medical information please contact: info@altanpharma.com

For stock control queries please contact: info@altanpharma.com

To access the full recall: Class 4 Medicines Defect Information: Altan Pharma Limited, Phenylephrine 0.08 mg/ml - solution for injection/infusion, EL(22)A/29