For Immediate Release
Company name: DAIICHI SANKYO COMPANY, LIMITED
Representative: Joji Nakayama, Representative Director, President and CEO
(Code no.: 4568, First Section, Tokyo Stock Exchange)
Please address inquiries to Noriaki Ishida, Executive Officer,
Vice President, Corporate Communications Department
Telephone: +81-3-6225-1126
http://www.daiichisankyo.com
Daiichi Sankyo Announces Voluntary Recall of Freeze-dried Live Attenuated Measles, Rubella Combined Vaccine “Kitasatodaiichisankyo” and Freeze-dried Live Attenuated Measles Virus Vaccine “Kitasatodaiichisankyo”
Tokyo, Japan (October 30, 2015) – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that it has decided to carry out a voluntary recall of two products manufactured by its group company, Kitasato Daiichi Sankyo Vaccine Co., Ltd. (hereafter, Kitasato Daiichi Sankyo). The two products, Freeze-dried Live Attenuated Measles, Rubella Combined Vaccine “Kitasatodaiichisankyo” and Freeze-dried Live Attenuated Measles Virus Vaccine “Kitasatodaiichisankyo,” are being recalled due to results of stability monitoring revealing a possibility that potency of the measles virus falls below the approved standard within the product shelf-life.
At present, there is no report of any impact to efficacy and safety concerning the aforementioned vaccines. In addition, serial numbered products apart from those indicated for recall are currently being checked to confirm whether their potency fulfills the approved standard
Daiichi Sankyo and Kitasato Daiichi Sankyo wish to express their sincere apologies to medical professionals and the families of children who received or are targeted for inoculation with Freeze-dried Live Attenuated Measles, Rubella Combined Vaccine “Kitasatodaiichisankyo” or Freeze-dried Live Attenuated Measles Virus Vaccine “Kitasatodaiichisankyo” for any worry caused as a result of this recall. Kitasato Daiichi Sankyo is putting every effort into investigating the causes of the matter, and will endeavor to prevent any recurrence.
Products indicated for recall and serial numbers:
|
Product name
|
Packaging
|
Serial number
|
|
Freeze-dried Live Attenuated Measles, Rubella Combined Vaccine “Kitasatodaiichisankyo”
|
Bottle,
Containing dosage for 1 person
|
HF053A
HF054A
HF055A
HF056A
HF058A
HF059A
|
|
Freeze-dried Live Attenuated Measles Virus Vaccine “Kitasatodaiichisankyo”
|
Bottle,
Containing dosage for 1 person
|
MF005A
MF006A
|
Products not indicated for recall and serial numbers
|
Product name
|
Packaging
|
Serial number
|
|
Freeze-dried Live Attenuated Measles, Rubella Combined Vaccine “Kitasatodaiichisankyo”
|
Bottle,
Containing dosage for 1 person
|
HF060A
HF061A
|