Rienso 30mg/ml solution for infusion - Takeda UK Ltd - CLDA (15)A/02 - 16 March 2015
Takeda UK Ltd is recalling specific batches of Rienso 30mg/ml solution for infusion (Ferumoxytol).
Product information
CLDA number
CLDA (15)A/02
MDR number
07-03/15
Company name
Takeda UK Ltd
Product description
Rienso 30mg/ml solution for infusion (Ferumoxytol)
1 x 1 vial EU/1/12/774/001
1 x 6 vials EU/1/12/774/004
Batch number/ expiry
1 x 1 vial:
- 240789 Exp 31/08/2015
- 257893 Exp 31/10/2016
- 290707 Exp 31/10/2016
1 x 6 vials:
- 240675 Exp 31/08/2015
Brief description of problem
Further to the recall of Rienso batches in January 2015 (reference number CDLA (15)A/01), due to a change in the mode of administration Takeda has made the decision to withdraw the marketing authorisation for the above product in the EU. All stock of the listed batches, including any stock at ward level and in other locations within the hospital, should be quarantined and returned to the original supplier for credit immediately (by 1 April 2015 at the latest).
Company contact for medical information enquiries
Telephone: 01628 537900
Fax: 01628 526617
Email: DSO-UK@takeda.com