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UCB Japan “Cimzia Subcutaneous Injection 200mg AutoClicks” - Recall

Official notice

16 Oct 2026

Last checked

27 Oct 2026

RecallScope risk estimate:MediumCAA Japan

An official CAA Japan notice concerns UCB Japan “Cimzia Subcutaneous Injection 200mg AutoClicks” - Recall. A defect has been confirmed in which the needle does not fully retract after injection. Reason for recall: A defect has been confirmed in some lots in which the needle does not fully retract after injection. As this defect may leave the used needle exposed, the affected lots will be voluntarily recalled. The cause has been identified and countermeasures have already been implemented. Specific potential health effects: It has been confirmed that the full dose can be administered even if the needle does not fully retract after use. An exposed used needle may cause a needlestick injury, but any anticipated needlestick injury would be superficial. Systemic infection could occur only if several conditions were met in succession, so serious adverse health effects are considered highly unlikely. No serious adverse health effects attributable to this defect have been reported to date. Published 2026-10-16.

What to do now

All shipment destinations for the affected lots are known. The affected recipients will be notified of the recall, and the voluntary recall will be carried out promptly.

Recall number

2-12993

Official notice

2026-10-16

The hazard

A defect has been confirmed in which the needle does not fully retract after injection. Reason for recall: A defect has been confirmed in some lots in which the needle does not fully retract after injection. As this defect may leave the used needle exposed, the affected lots will be voluntarily recalled. The cause has been identified and countermeasures have already been implemented. Specific potential health effects: It has been confirmed that the full dose can be administered even if the needle does not fully retract after use. An exposed used needle may cause a needlestick injury, but any anticipated needlestick injury would be superficial. Systemic infection could occur only if several conditions were met in succession, so serious adverse health effects are considered highly unlikely. No serious adverse health effects attributable to this defect have been reported to date.

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.

Lots

426473 8

Expiry Dates

2025-09-29, 2025-11-17, 2025-10-09, 2025-12-01, 2025-12-23, 2025-12-17, 2026-03-16, 2026-02-12, 2026-02-19, 2026-04-20, 2026-03-03, 2026-04-07, 2026-05-21, 2026-06-02

Recall Numbers

2-12993

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Affected products

Product 1

セルトリズマブ ペゴル(遺伝子組換え) シムジア皮下注200mgオートクリックス

Hazard

A defect has been confirmed in which the needle does not fully retract after injection. Reason for recall: A defect has been confirmed in some lots in which the needle does not fully retract after injection. As this defect may leave the used needle exposed, the affected lots will be voluntarily recalled. The cause has been identified and countermeasures have already been implemented. Specific potential health effects: It has been confirmed that the full dose can be administered even if the needle does not fully retract after use. An exposed used needle may cause a needlestick injury, but any anticipated needlestick injury would be superficial. Systemic infection could occur only if several conditions were met in succession, so serious adverse health effects are considered highly unlikely. No serious adverse health effects attributable to this defect have been reported to date.

Where it was sold

Retailer information is not currently available in RecallScope. Check the official notice for distribution details.

Location 1

JP · Japan

Affected area 1

JP · Japan

Company & contacts

Brand

ユーシービージャパン

Manufacturer

ユーシービージャパン株式会社

Phone

0120-093-189

Brand: ユーシービージャパン. Contact: ユーシービージャパン株式会社 品質保証部. Phone 0120-093-189.

Source & status

Source

Tier

official

Category

HEALTH

Official classification

PMDA Class II — 回収

Recall details

Recall number

2-12993

Event id

CAA-00000035976

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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