Class 4 Medicines Defect Information: Albireo AB, Bylvay 1200 micrograms Hard Capsules, EL (23)A/01
Albireo AB has informed the MHRA that there is a typographical error with the text on the side panel of the bottle label for a specific batch of Bylvay 1200 micrograms Hard Capsules.
MDR number
MDR 135-12/22
Company name
Albireo AB
Product name
Bylvay 1200 micrograms Hard Capsules, PLGB 36216/0004
| Batch number | Expiry date | Pack size | First distributed |
|---|---|---|---|
| W067208E | 01-2024 | 30 capsules | 17 October 2022 |
Active Pharmaceutical Ingredient: Odevixibat
Brief description of the problem
Albireo AB has informed the MHRA that the side panel of the bottle label of the above batch of Bylvay 1200 micrograms Hard Capsules erroneously reflected the content of the active ingredient as 400 micrograms odevixibat (as sesquihydrate).
This should state: “Each capsule contains 1200 micrograms odevixibat (as sesquihydrate)”.
The labelling on the main panel of the bottle label and the outer carton are printed correctly to reflect the capsule content as 1200 micrograms odevixibat. The patient information leaflet (PIL) also states that each Bylvay 1200 micrograms Hard Capsule contains 1200 micrograms odevixibat.
Advice for healthcare professionals
Healthcare professionals should note that there is no risk to product quality and efficacy, therefore the affected batch is not being recalled.
Healthcare professionals should exercise caution when dispensing or supplying this product. Please refer to the correct information on the content of the active ingredient as stated on the main panel of the bottle label and the outer carton of the pack.
Advice for patients
This notification relates to a typographical error on the label of the bottle for one affected batch of product. The medicine itself is not affected and patients do not need to take any action.
Further Information
For medical information and stock control queries please contact: medinfo@Albireopharma.com
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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