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Fybogel Hi-Fibre and Fybogel Orange - potential risk of contamination with metal particles

Read the official alert on GOV.UK — MedRegWatch re-presents it; GOV.UK is the authoritative source.

TypeMedicines recall/notification
Issued19 Jun 2014
ReferenceEL (14)A/04
Product licencesPL 00063/0026 · PL 00063/0064

19 June 2014

Class 2 medicines recall

Action within 48 hours

Pharmacy level

MDR 18-03/14

Product details

Reckitt Benckiser Healthcare (UK) Limited

Fybogel Hi-Fibre (Ispaghula Husk) - PL 00063/0064

Fybogel Orange (Ispaghula Husk) - PL 00063/0026

Alert details

  • Product: Fybogel Hi-Fibre
    • Batch number: 402410
    • Expiry date: 1 Jan 17
    • Pack Size: 1 x 30
    • First distributed: 21/05/2014
  • Product: Fybogel Orange
    • Batch number: 401610
    • Expiry date: 1 Jan 17
    • Pack Size: 1 x 30
    • First distributed: 04/03/2014

Further to drug alert EL (14)A/04 issued 12 March 2014, Reckitt Benckiser Healthcare (UK) Limited is recalling a further 2 batches of Fybogel, listed above, due to a potential risk of contamination with metal particles.

Remaining stock of these batches should be quarantined and returned to the original supplier for credit. For stock enquiries, please contact Reckitt Benckiser (UK) Ltd Customer Services on 01753 506950.

For medical information enquiries please contact Reckitt Benckiser (UK) Ltd Medical Information Department on 0500 455456.

Recipients of this drug alert should bring it to the attention of relevant contacts by copy of this letter. Local area teams are asked to forward this to relevant clinics, general practitioners and community pharmacists.

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