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
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| FE221001 | 05/2024 | 10 bags of 100ml | April 2022 |
Active Pharmaceutical Ingredient: Phenylephrine hydrochloride
Brief description of the 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 for 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 for 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.
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