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Sanwa Kagaku Kenkyusho "Diclofenac Sodium Tape 15mg ‘Sanwa’" and 3 other products - Recall
Official notice
15 Jul 2026
Last checked
27 Oct 2026
An official CAA Japan notice concerns Sanwa Kagaku Kenkyusho "Diclofenac Sodium Tape 15mg ‘Sanwa’" and 3 other products - Recall. Manufacturing and process controls were found to have been performed using methods differing from those in the approval document, and deficiencies in records were identified. Reason for recall: At the manufacturing site for these products, manufacturing and process controls were found to have been performed using methods differing from those in the approval document, and deficiencies in records were identified. It was therefore determined that product quality could not be adequately assured, and the affected products will be voluntarily recalled. Specific potential health effects: Stability test results and test results for retained samples and other samples within their expiration dates have confirmed that product quality is unaffected. Consequently, safety and efficacy are unaffected, and serious health effects are not considered likely. No health effects related to this matter have been reported to date. Published 2026-07-15.
What to do now
All pharmaceutical wholesalers and other recipients supplied with products from the recalled lots have been identified. They will be notified of the recall in writing, and the products will be recalled.
Recall number
2-12891
Official notice
2026-07-15
The hazard
The hazard
Manufacturing and process controls were found to have been performed using methods differing from those in the approval document, and deficiencies in records were identified. Reason for recall: At the manufacturing site for these products, manufacturing and process controls were found to have been performed using methods differing from those in the approval document, and deficiencies in records were identified. It was therefore determined that product quality could not be adequately assured, and the affected products will be voluntarily recalled. Specific potential health effects: Stability test results and test results for retained samples and other samples within their expiration dates have confirmed that product quality is unaffected. Consequently, safety and efficacy are unaffected, and serious health effects are not considered likely. No health effects related to this matter have been reported to date.
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Check the official notice for the affected products and next steps.
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Affected products
Product 1
Hazard
Where it was sold
Where it was sold
Retailer information is not currently available in RecallScope. Check the official notice for distribution details.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand
Manufacturer
Phone
Brand: 三和化学研究所. Contact: 株式会社三和化学研究所 品質保証部. Phone 052-951-8130.
Source & status
Source & status
Recall details
Recall details
Recall number
Event id
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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