The text starts here.

News Release

FOR IMMEDIATE RELEASE
October 22, 2003

Voluntary Product Recall of SKAINAR(R) ANTITUSSIVE & EXPECTORANT

Eisai Co., Ltd. (Headquarters: Tokyo, President: Haruo Naito) announced today it is conducting a voluntary recall of SKAINAR(R) ANTITUSSIVE & EXPECTORANT, a consumer health care medication for cough and expectoration (hereinafter referred to as the "Product"), from October 22, 2003.


1. Reason for the voluntary product recall

  Within the package insert, an incorrect precaution description has occurred as noted below :

PRECAUTION "Consultation Requirement"
In the following cases, immediately discontinue taking this product and consult with a doctor or pharmacist by referring to this insertion.
Incorrect : In the case if you use this medicine for 5 to 6 days and the symptoms have not improved....
Correct : In the case if you use this medicine for 5 to 6 times and the symptoms have not improved....

The involved production lots of the product have been recalled effective October 22, 2003. The potential for serious adverse events even after usage for 5 to 6 days is limited; however, from the perspective of increased drug safety, the Company decided to initiate a voluntary recall. This recall involves only the package insert and not product quality.


Eisai manages its product insert descriptions under a stringent management system; however, the Company expresses its apologies to consumers and others for whom this action may cause inconvenience.


The Company will reinforce observance of existing procedures in the management of descriptions in insertions to prevent recurrence of a similar event.



2. Manufacturer
Manufacturer's Name : Eisai Co., Ltd.
  Headquarters : 4-6-10 Koishikawa, Bunkyo-ku, Tokyo, Japan
  Production Plant : Eisai Co., Ltd., Kawashima Plant
  Address of Plant : Takehaya-machi 1, Kawashima-cho, Hashima-gun, Gifu, Japan
3. Product outline
1) Name and other information
  Name : SKAINAR(R) ANTITUSSIVE & EXPECTORANT
  Approval Number : # (61AP) 4441
  Active Ingredients (two capsules, dose per day for an adult, contains the active ingredients indicated below) :
 
Dextromethorphan hydrobromide 60mg
Diprophylline 200mg
Lysozyme hydrochloride 40mg (potency)
  Approval Date : July 7, 1986
  Date of Launch : July 1, 1987
2) Indication
  cough and expectoration
4. Details of the Product to be recalled
1) Lot Number of respective Products
  Lot Number Distributed Items Distribution Term
05A10K 36,790 pcs May 12, 2000 to December 4, 2001
17B65K 16,580 pcs November 14, 2001 to March 19, 2003
2YA97K 29,670 pcs November 19, 2002 to October 15, 2003
2YA98K 10,040 pcs May 14, 2003 to October 15, 2003
2) To whom the Product was supplied
  From Eisai to wholesalers who then distributed the Product to pharmacies and drugstores in Japan
5. Expected adverse events
For avoiding chronic administration for cases with no sign of active effects with this medicine, it is noted in the precautions that users should consult their doctor or pharmacist before continuing use in the case that no improvement is observed. This Product is not limited the period of use if it is effective, therefore it is possible that this Product can be used for 5 to 6 days. Even if this Product is taken for 5 to 6 days instead of taking 5 to 6 times, there is a little possibility of serious adverse events. Eisai has not received any adverse events report arising from the Product's use for 5 to 6 days.
6. Contact
Eisai Co., Ltd.
Public Relations Department
03-3817-5120