MHRA 发布二级药品召回：Becton Dickinson ChloraPrep 2% 1mL 与 ChloraPrep Frepp 2% 1.5mL 涂抹器 EL(26)A/26
Class 2 Medicines Recall: Becton Dickinson UK Ltd, ChloraPrep 2% 1mL and ChloraPrep Frepp 2% 1.5mL applicators, EL(26)A/26
MHRA 缺陷药品报告中心发布二级药品召回（DMRC-39617055），Becton Dickinson UK Ltd 因包装过程中可能存在无菌破损，召回 ChloraPrep 2% w/v / 70% v/v 1mL 涂抹器和 ChloraPrep Frepp 2% w/v / 70% v/v 1.5 mL 涂抹器所有有效期至 2028 年 2 月（含）的批次。
通知列出受影响批次的有效期范围与包装环节无菌破损这一原因，便于相关机构核对库存并执行隔离退货。
Contents
- DMRC reference number
- Marketing Authorisation Holder
- Medicine Details
- Affected Lot Batch Numbers
- Background
- Advice for Healthcare Professionals
- Advice for Healthcare Professionals to Provide to Patients
- Additional information
- Download document
DMRC reference number
DMRC - 39617055
Marketing Authorisation Holder
Becton Dickinson UK Ltd
Medicine Details
ChloraPrep 2% w/v / 70% v/v cutaneous solution 1mL applicators
PL: 05920/0002
Active Ingredient: chlorhexidine gluconate 2%w/v and isopropyl alcohol 70% v/v
SNOMED code: 40818111000001106
GTIN: 20885403491761 10885403491764
ChloraPrep Frepp 2% w/v / 70% v/v cutaneous solution 1.5 mL applicators
PL: 05920/0002
Active Ingredient: chlorhexidine gluconate 2%w/v and isopropyl alcohol 70% v/v
SNOMED code: 12775311000001103
GTIN: 27613203022099
Affected Lot Batch Numbers
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| All lots with an expiry date up to and including 02/2028 * | All lots with an expiry date up to and including 02/2028 | ChloraPrep 1mL Applicator: 60 applicators | 11/09/2023 |
| All lots with an expiry date up to and including 01/2028 * | All lots with an expiry date up to and including 01/2028 | ChloraPrep Frepp™ 1.5 ml Applicators: 20 applicators | 09/01/2024 |
* For a full list of impacted batches, see Annex 1
Background
Becton Dickinson UK Ltd are recalling batches of ChloraPrep 2% w/v / 70% v/v cutaneous solution 1mL applicators and ChloraPrep Frepp 2% w/v / 70% v/v cutaneous solution 1.5 mL applicators due to a potential breach of sterility in the packaging process. The recall applies to all batches with an expiry date up to and including 02/2028. Batches with an expiry date after 02/2028 are not impacted.
This defect could increase the risk of the applicator device being contaminated with pathogens, which could lead to increased infection rates for the patients. The number of impacted units in each batch is unknown, therefore the batches included in Annex 1 are being recalled as a precautionary measure.
The full list of impacted batch details is included in Annex 1.
Advice for Healthcare Professionals:
Stop supplying the affected batches. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
Advice for Healthcare Professionals to Provide to Patients:
No further action is required by patients as this product is used by healthcare professionals only and they will have taken the action to remove this product from use.
The recall is a precautionary measure to mitigate any additional risk of infection.
Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.
Additional information:
For all medical information enquiries and information on this product, please email [email protected], or telephone 08000437546.
For stock control enquiries please email [email protected], or telephone 01707351330.
Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
Yours faithfully
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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来源：MHRA 药品召回与缺陷通报 · gov.uk