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FOR IMMEDIATE RELEASE
October 22, 2003
Voluntary Product Recall of SKAINAR ANTITUSSIVE & EXPECTORANT
Eisai Co., Ltd. (Headquarters: Tokyo, President: Haruo Naito) announced today it is conducting a voluntary recall of SKAINAR 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
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Within the package insert, an incorrect precaution description has occurred as noted below :
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| PRECAUTION "Consultation Requirement" |
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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.... |
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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.
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2. Manufacturer
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Manufacturer's Name |
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Eisai Co., Ltd. |
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Headquarters |
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4-6-10 Koishikawa, Bunkyo-ku, Tokyo, Japan |
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Production Plant |
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Eisai Co., Ltd., Kawashima Plant |
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Address of Plant |
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Takehaya-machi 1, Kawashima-cho, Hashima-gun, Gifu, Japan |
3. Product outline
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Name and other information |
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Name |
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SKAINAR ANTITUSSIVE & EXPECTORANT |
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Approval Number |
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# (61AP) 4441 |
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Active Ingredients (two capsules, dose per day for an adult, contains the active ingredients indicated below) : |
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Dextromethorphan hydrobromide |
60mg |
| Diprophylline |
200mg |
| Lysozyme hydrochloride |
40mg (potency) |
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Approval Date |
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July 7, 1986 |
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Date of Launch |
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July 1, 1987 |
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Indication |
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cough and expectoration |
4. Details of the Product to be recalled
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Lot Number of respective Products |
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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 |
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From Eisai to wholesalers who then distributed the Product to pharmacies and drugstores in Japan |
5. Expected adverse events
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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
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Eisai Co., Ltd. Public Relations Department 03-3817-5120 |
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