Regulatory pipeline
Drug pipeline & approvals
Review approvals, regulatory notices, and agency-driven pipeline updates in the same premium layout used on the homepage.
1639 tracked updates • 22 agencies indexed
Regulatory stream
Latest pipeline updates
Showing 200 of 1,639 tracked regulatory updates
Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 16-18 June 2026
CVMP opinions on veterinary medicinal productsThe Committee adopted a negative opinion for a marketing authorisation for Scovella (velagliflozin), a product classified as…
BD MaxPlus ™ Connector Minibore Extension Set
BD has identified a mechanical issue with internal sterilization equipment resulting in potential under dosing of product during processing, which may have resulted in product not being sterilized correctly.
Update on the PATHWAYS clinical trial
As with all clinical trials, the MHRA’s top priority is the safety and wellbeing of the trial participants.
Δήλωση Αποθεμάτων Φαρμάκων Ανθρώπινης Χρήσης
ΑΝΑΚΟΙΝΩΣΗ ΣΧΕΤΙΚΑ ΜΕ ΔΙΟΡΘΩΤΙΚΟ 2025/90805 ΣΤΟΝ ΚΑΝΟΝΙΣΜΟ 1223/2009
[IBENTO][IBENTO]The report for the PMDA Asia office GCP workshop 2026 has been posted.
[IBENTO][IBENTO]The report for the PMDA Asia office GMP Workshop Training 2026 has been posted.
식약처장, 의료제품 허가·심사 혁신방안 CEO 간담회 개최
의료용 마약류 졸피뎀 처방할 때 투약내역 확인하세요
식용 복어와 혼동하기 쉬운 잡종 복어, 섭취하지 마세요
24시간 AI 식품 민원 상담시스템 '온고지신' 운영 시작
M/s.Neuland Laboratories Ltd – Bempedoic acid IH and 3 items
[International Certificates] 2026-06-19 00:00:00.0
Julie Enevold Brooker oraz Gábor Sztaniszláv zostali wybrani do Zarządu Związku Pracodawców Innowacyjnych Firm Farmaceutycznych INFARMA
Warning on promoting newly licensed prescription-only medicines and unlicensed medicines for weight management
The MHRA, Advertising Standards Authority, and the General Pharmaceutical Council have issued a warning to businesses seeking to promote newly authorised medicines, as well as those that do not yet have a marketing authorisation.
Decision: Orphan registered medicinal products
A list of authorised orphan medicinal products registered by the UK licensing authority.
Κύρια σημεία συνεδρίασης της Επιτροπής Αξιολόγησης Κινδύνου Φαρμακοεπαγρύπνησης (PRAC), 8 – 11 Ιουνίου 2026
Atellica CH Enzymatic Hemoglobin A1c (A1c_E) assay
Siemens Healthineers has confirmed, through internal investigation of customer complaints, the potential for intermittent well-to-well bias affecting the A1c_E/A1c_H assay when used on the Atellica CH and Atellica CI systems. This observed bias does not affect every A1c_E reagent lot or reagent pack. However, affected wells cannot currently be identified prospectively, therefore all in-date lots are considered potentially impacted until further notice. Under certain circumstances, this issue may
MED-RX Wound Care Kit
CHS was notified by BD Canada that they are conducting a recall of specific lots of the BD Chloraprep™ Clear - 1 ml and Clear 1.5 ml applicators. The BD Chloraprep™ Clear - 1 ml and Clear 1.5 ml applicators with paper lidding are being recalled due to potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area.CHS Ltd uses these Chloraprep applicators in the medical devices they manufacture.
Tibsovo
Guidance: Advice for consumers
Information about suspected side effects of e-cigarettes and how to report side effects.
Minimum service from 20 July till 3 August
Pharmaceutical innovation key to delivering G7 leaders’ growth agenda
[보도참고] 주사기 생산 등 수급 동향 발표
의료용 마약류 오남용 철저한 감시와 엄정한 제재로 단호히 끊어내겠습니다
식약처, 전국 어린이집 6,173곳 위생점검
Patient Recruitment and Community Engagement Issues in the Spotlight from ACRP 2026
2026 World Food Safety Day Capacity Building Event For NAFDAC Officers
Project Orbis
Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster.
Ανάκληση της παρτίδας H0444C του φαρμακευτικού προϊόντος NILOTINIB/TEVA caps 200mg/cap BT x 112
Guidance: COVID-19 test validation approved products
Find out which COVID-19 test products have been approved.
Polyflex powder for suspension; Cracked vials
Glass vials may be cracked in the affected lots.
Plum™ Precision IV Pumps
In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.
Single Use Distal Cover
Olympus has developed a newly designed version of the MAJ-2315 to help mitigate the risk of incorrect attachment of the distal cover to the scope. Users should stop using the old design and set aside for return once the new design of the MAJ- 2315 has been received.
HALYARD* PUREZERO* Ultraviolet* Nitrile Exam Gloves
The issue surrounding this field action is related to not meeting the minimum breakthrough time of 30 minutes for n-Heptane required for European Type B performance per ISO 374-1:2016+A1:2018 and EN 16523-1:2015+A1:2018. No other product codes or lots of gloves are impacted in this field action.
식약처, 광주·전라·제주 비무균의약품 업체와 ‘식의약 정책이음 지역현장 열린마당’ 개최
Pharmaceutical industry mobilizes to support response to the Ebola Bundibugyo virus disease outbreak and calls for a system that enables rapid response and sustained R&D investment
K-축산물 세계로, 식약처가 함께한다!
[보도참고] 식약처, 첨단바이오의약품 개발 및 분석기술의 A.I. 활용 미래 전망
[보도참고] 식약처, 시험·검사 역량 강화를 위한 동물용의약품 시험법 설명회 개최
식약처, 유럽 등 해외 규제기관과 최초로 의약품 국제 공동 심사
M/s Shakti Lifescience Private Limited, – Abiraterone Acetate USP and 8 items
[International Certificates] 2026-06-17 00:00:00.0
식약처, 표준물질생산기관 국제 인정 획득
[보도참고] 제조일자 없는 '빙과' 회수 조치
Leveraging Artificial Intelligence for Clinical Trial Recruitment and Retention
Reimagining the Clinical Research Coordinator in the Age of AI: A Commentary
Bridging the Gap in Clinical Research: A Theory-Driven, Site-Centric Framework for AI Adoption and Literacy
Implementation of AI for Future Clinical Data Review: A Literature Review
How AI and Regulatory Changes are Advancing Product Development
Clinical Research in 2026: The Rise of Connected Development
Clinical Trials Without the Traffic Jams: AI’s Role in Accelerating Discovery
Self-Service Check-In, Serious Back-End: Untangling the Technology Behind Frictionless Clinical Trial Intake
Building the Bridge: Why Embedding Clinical Research in the Patient Journey is the Defining Opportunity of This Moment
Integrating Behavioral Health Support into Clinical Trial Participant Retention Strategies
ACE-inhibitors: Be aware of the distinction between bradykinin- and histamine-mediated angioedema, as treatment strategies differ significantly
Healthcare professionals should be aware of the potential for delayed onset of angioedema and the distinction between bradykinin- and histamine-mediated cases, as treatment strategies differ significantly and bradykinin-mediated angioedema does not respond to standard treatment.
ANMAT prohíbe el tránsito interjurisdiccional de productos médicos de IGMA INSUMOS HOSPITALARIOS S.R.L.
Lancora Tablets; Broken / partial tablets in blister pack
Presence of partial tablets in the blister packs.
Unauthorized soft-shelled hyperbaric chambers may pose serious health risks 2026-06-16
Health Canada has received several complaints related to the use of unauthorized soft-shelled hyperbaric chambers and they are increasingly found in wellness centres in Canada. Soft-shelled hyperbaric chambers are regulated as medical devices under the Food and Drugs Act and Medical Devices Regulations. These devices are unlicensed, may be ineffective for the purposes for which they are advertised and may pose serious health risks for users and those in close proximity, including death.Soft-shel
GE Healthcare Integrated and Stand-Alone Resuscitation systems
GE HealthCare has become aware of a potential issue involving the air-oxygen blender knob shaft on certain (serial number specific) integrated and stand-alone Resuscitation systems. In some cases, the blender knob shaft can loosen, which can affect the delivered oxygen concentration. If this occurs, the system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient.
Class 3 Medicines Recall: Orbit Pharma Limited, Cyclizine Lactate 50 mg/ml Solution for injection, EL(26)A/29
Orbit Pharma Limited is recalling a specific batch of Cyclizine Lactate 50 mg/ml Solution for injection as a precautionary measure due to Good Manufacturing Practice (GMP) deficiencies identified at the manufacturing site.
High-Level Virtual Meeting of African Heads of States, Governments and Partners on Ebola Bundibugyo virus disease outbreak
INVITATION CONFERENCE DE PRESSE : Résultats 2026 du baromètre 360° de l’attractivité de la France pour l’industrie pharmaceutique
[부처합동] 위조 화장품 근절을 위해 정부와 업계가 함께 나선다!
[ANZEN]PMDA Risk Communications: Omeprazole etc. posted
[ANZEN]Revisions of PRECAUTIONS: Lithium carbonate , etc. posted
Agenda for August 2026 Pharmacology and Therapeutics Advisory Committee (PTAC) meeting
[보도참고] 식약처, 브라질 위생감시청(ANVISA) 등과 의료제품, 화장품 분야에서 규제조화 협력 확대하기로
M/s. Ravi Biolife Private Limited – Methotrexate EP/USP
[International Certificates] 2026-06-16 00:00:00.0
M/s. Vasudha Pharma Chem Limited, – Aripiprazole Ph.Eur and 23 items
[International Certificates] 2026-06-16 00:00:00.0
M/s Alembic Pharmaceuticals Limited – Pinaverium Bromide IH and 52 items
[International Certificates] 2026-06-16 00:00:00.0
M/s Cohance Lifesciences Limited, – Levomepromazine Maleate EP/BP
[International Certificates] 2026-06-16 00:00:00.0
M/s Themis Medicare (l) Ltd – Ketamine Hydrochloride IP/BP/USP
[International Certificates] 2026-06-16 00:00:00.0
Constitution of Consultancy Committee of Key Stakeholders for Advice on Suo-Motu Disclosure under Section 4 of the RTI Act, 2005 in CDSCO
[Circulars] 2026-Jun-16
[보도참고] 식약처, 디지털의료기기 업계와 임상평가 제도 이해를 위한 현장 소통
Unique liaison programme set to reinforce close collaboration between MHRA and FDA
MHRA and FDA liaison programme announced to improve regulatory collaboration and support long-standing international partnership.
Field Safety Notices: 8 -12 June 2026
List of Field Safety Notices for 8-12 June 2026
Improved early warning systems needed to reduce medicines supply risks, says ABPI
The UK should seek to be a European leader for rare disease medicine, says new report
ABPI celebrates a month of major investment commitments into UK life sciences
Medicine levy makes the UK un-investable, say pharma leaders
Are NHS patients keeping up with European neighbours on access to new medicines?
Time to emphasise the economics in health economics
Latest Disclosure UK data: higher R&D spend, greater transparency and more partnership with the NHS
UK medicines investment: the case for improving the UK commercial environment
Making Wales a destination for industry clinical trials and medical research
ABPI Regulatory Science symposium 2025
Why the pharmaceutical industry needs NHS data to develop new medicines
Disclosure UK 2024: new record for transparency, with nine in ten healthcare professionals named in database
Speedy Anna is now award-winning
Getting ready for the Windsor Framework: ensuring continuity of UK medicines supply beyond 1 January 2025
Comparing new medicine availability across Europe
mRNA technology: navigating preclinical research for rare diseases
June’s story of sickle cell
Principles for analysis and use of health data by ABPI members
MHRA’s new International Recognition Procedure (IRP): how does it shape up?
My sons have taught me more than I could ever teach them
Medics 4 Rare Diseases: We need services to diagnose people earlier so they can have access to treatments
A Breath of Fresh Air: A Welsh project to improve management of Cystic Fibrosis
Paving the way to sustainability: transforming pharmaceutical industry practices
Could more medicines be recommended for routine commissioning rather than spending time in the Cancer Drugs Fund?
Reflections from NICON22
Working together, we are all determined to create more medicines for pregnant women
Απαγόρευση διακίνησης και διάθεσης του προϊόντος «LIGHT DIGEST Vanilla»
Ανάκληση παρτίδας του προϊόντος «ΤΟΛΥΠΙΑ XRAY DIAM 5CM 40X40» REF 24-0460
EMA Management Board: highlights of June 2026 meeting
Crisis preparedness and responseThe Management Board welcomed EMA’s support to African regulators in the context of the Ebola outbreak in the Democratic Republic of Congo and…
MEPs and partner organisations call for investments in vaccine R&D to support EU and global health security and preparedness
Bijdragen
Eκτέλεση προϋπολογισμού ΕΟΦ μηνός Μαϊου 2026
Orange You Glad You Used the Right Form?
식약처, 염소 고기 등 여름 보양식 안전관리 실시
식약처-지방정부, 식품 등 온라인 부당광고 합동점검 225건 적발
MHRA scientific leader recognised in 2026 King’s Birthday Honours
Dr Nicola Rose, Executive Director of Science and Research at the Medicines and Healthcare products Regulatory Agency (MHRA), has been appointed an OBE in the 2026 King’s Birthday Honours, for services to science and public health.
América Latina llega a la mesa global de la salud: Yaneth Giha es elegida Vicepresidenta del Consejo de IFPMA
Customizing Clinical Trial Content for Boston Scientific’s Device Trials
Lower dose needle-free allergy treatment approved for younger children
As with any medicine, the MHRA will keep the safety and effectiveness of the adrenaline nasal spray under close review.
Decision: Medical devices given exceptional use authorisations
List of manufacturers and their medical devices granted an exemption by MHRA. The list also includes manufacturers whose exemption expired or was cancelled.
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 June 2026
PRAC concludes evidence of potential risk of neurodevelopmental disorders in children born to men treated with valproate is inconsistent Committee recommends updating product…, Agenda Agenda of the PRAC meeting 8-11 June 2026Draft Reference Number: EMA/PRAC/115322/2026…, PRAC statistics: June 2026 , , Glossary Safety signal assessments. A safety signal is information which suggests a new potentially causal association, or a new aspect of a known association between…
Εξάρθρωση κυκλώματος παράνομης παραγωγής και εμπορίας φαρμάκων
[보도참고] 식약처, 의약품 부작용 피해구제 활성화를 위한 의료현장 홍보 실시
식약처장, 오성규 애국지사님 등 보훈원 국가유공자 위문
[YAKKYOKUKATA]PDG March 2026 News posted
Leveraging Prior Knowledge – When Do Sponsors Not Have to Recreate the Wheel? Breaking Down FDA’s New Draft Guidance From a Nonclinical and Clinical Perspective
[보도참고] 식약처, 올해 독감백신 약 2,740만 명분 국가출하승인 준비...신속출하 지원
[보도참고] 디지털의료기기 진단보조 분야 중심으로 성장
Swissmedic publishes its Annual Report and financial statements for 2025
On 12 June 2026, the Federal Council approved the reporting of Swissmedic, the Swiss Agency for Therapeutic Products, for the previous year, thereby discharging the Swissmedic Agency Council of its responsibilities for 2025. It was a year of transition for the Agency, with significant changes at the helm of the organisation and the marked deterioration of the financial situation. The almost 32 million Swiss franc loss in financial year 2025, which is covered by reserves, was the result of a fund
Przedłużenie dodatkowego świadectwa ochronnego mogłoby dziesięciokrotnie zwiększyć inwestycje w badania i rozwój w Europie
First GLP-1 tablet for weight loss approved in the UK
Having met the MHRA’s rigorous standards of safety, quality and effectiveness, the semaglutide tablet has been approved in the UK for weight loss and weight management.
MHRA landmark report reveals public views on AI in healthcare
The MHRA is publishing the results of an extensive public consultation which will inform the recommendations of the AI Commission and future regulations.
Regulation of medical devices in Northern Ireland
Information about how the MHRA regulates medical devices in Northern Ireland and what legislation applies to manufacturers and suppliers.
Clinical Research Career Pathways Survey
What we heard: Draft guidance on decentralized clinical trials
Health Canada published the Draft guidance on Decentralized Clinical Trials on December 23, 2025, with a public consultation held until February 21, 2026. This report summarizes the feedback received during this consultation.
Product Monograph Brand Safety Updates
Product Monograph Brand Safety Updates for Submissions cleared between 01-05-2026 and 31-05-2026
Διακήρυξη υπ. Αριθ. 0/2/2026 Ηλεκτρονικού Ανοικτού κάτω των Ορίων Διαγωνισμού για την Προμήθεια μονάδων αποθήκευσης και υπηρεσιών μετάπτωσης
ETMS 70 mm Cooled Coil
A potential issue manifests as an electrical arc within the coil itself that, when occurs, leads to a relatively loud popping sound, which can startle the patient or operator.
Aptima HIV Quant Dx Assay, HCV Quant Dx Assay, and HBV Quant Assay Software
This notification is to inform Panther and Panther Fusion users that assay installer (version 2.0.0.9) including the Aptima HIV Quant Dx Assay, HCV Quant Dx Assay, and HBV Quant Assay software was installed on Panther and Panther Fusion systems prior to Health Canada approval.The Aptima HIV Quant Dx Assay, HCV Quant Dx Assay, and HBV Quant Assay software included in assay installer version 2.0.0.9 have not been approved by Health Canada but have been validated and released. Based on this, the co
Regulation of AI in Healthcare
The MHRA is seeking evidence on the regulation of AI in healthcare to inform the recommendations of the National Commission into the Regulation of AI in Healthcare.
EMA’s 2025 annual report shows strong approval numbers for human and veterinary medicines
Today, EMA released its 2025 annual report, highlighting progress in bringing innovative, safe and effective medicines to patients. The report outlines the most important…
Research: National Commission into the Regulation of AI in Healthcare: research, engagement and call for evidence findings
Findings from the National Commission into the Regulation of AI in Healthcare's call for evidence and wider research and engagement activities.
L'industrie pharmaceutique appelle le G7 à investir dans l'innovation pour stimuler la compétitivité, la résilience et la croissance
Ανάκληση παρτίδων του φαρμακευτικού προϊόντος IMULDOSA C/S.SOL.IN 130MG/26ML (5MG/ML)
Medical devices: ask for a regulatory advice meeting from the MHRA
How to apply for a regulatory advice meeting on medical devices and in vitro diagnostic devices.
Pharmaceutical industry calls on G7 to invest in innovation to drive competitiveness, resilience, and growth
[보도참고] 주사기 생산 등 수급 동향 발표
[SHINSA]List of Approved Medical Devices: April 2004 to September 2025
식약처, ‘항산화·저속노화’ 내세운 하스카프베리 식품 등 부당광고 21개소 적발
Submission of Compliance for lmported/manufactured Hair Color Cosmetics Products as per Cosmetics Rules, 2020 and applicable BIS Standards
[Circulars] 2026-Jun-11
ACRP Fellow Encourages Flexibility, Creativity, and Persistence in Clinical Research
ANMAT consolidó su participación en los principales espacios internacionales de regulación farmacéutica
Selenia Dimensions 2D/3D Mammography Systems
Hologic is initiating this voluntary field safety corrective action because the vertical travel assembly on 3Dimensions and Selenia Dimensions systems may experience internal bolt failure over time. The vertical travel assembly contains eight internal bolts that secure the c-arm to the assembly. Devices with loose, missing or broken bolts may exhibit shaking, vibration or uncommanded c-arm motion.
Nicotine Pouch Recall; No market authorization
Product sold without market authorization (DIN) in Canada.
Opportunities for patients and the public to be involved in the work of the MHRA
Pioneering AI health innovations regulatory sandbox launched
The London sandbox is a secure environment designed to safely test AI-enabled devices in a real-world environment so patients can benefit more quickly.
WuXi AppTec’s 1260H Listing Brings the BIOSECURE Act Back to Center Stage
[보도참고] 식약처, 디지털의료기기 표시기재 가이드라인 개정
식약처, 의료기기 분야 정책 소통 위한 ‘식의약 정책이음 열린마당’ 개최
[부처합동] 중기부·농식품부·식약처, K-푸드 산업의 제조혁신과 글로벌 진출을 위해 손잡다!
[보도참고] 식약처, 화장품 안전성 평가 가이드라인 발간
AI 가짜 의사 앞세운 식품 과대광고 81억 원 상당 판매업체 검찰 송치
[IBENTO][IBENTO]Workshop on New Approach Methodologies (NAMs) Held following ICCR-20
Jean-François Brochard élu Président du Leem et composition du nouveau Bureau
Updated: List of Drugs for an Urgent Public Health Need
To notify of the addition of Rifampin for Injection, USP to the Urgent Public Health Need List for import by the Public Health Agency of Canada in the treatment of all forms of Tuberculosis.
MHRA launches AI sandbox to accelerate medicines development and improve safety
New AI sandbox will help make medicines safer, speed up development, and reduce reliance on animal testing.
Nipocalimab (Imaavy) authorised to treat adults and adolescents with generalised myasthenia gravis
As with all medicines, the MHRA will keep the safety and effectiveness of Nipolcalimab under close review.
Guedel Airway
During manufacture, some devices have been identified with occluded or partially occluded tips of the Guedel Airway.
Promotional material: National AI Commission: Ask Me Anything
Guidance: AI Airlock Simulation Workshops
Guidance: AI Airlock Sandbox Phase 2 Programme Report
ΛΙΣΤΑ ΦΑΡΜΑΚΕΥΤΙΚΩΝ ΣΚΕΥΑΣΜΑΤΩΝ ΠΕΡΙΟΡΙΣΜΕΝΗΣ ΔΙΑΘΕΣΙΜΟΤΗΤΑΣ 31 ΜΑΪΟΥ
ο ΕΟΦ είναι μέλος του Ευρωπαϊκού Δικτύου Ρυθμιστικών Αρχών Φαρμάκων (EMRN)
The guidance on digital and decentralised clinical trials (DCT) has been updated
RA Committee Townhall – How Agentic AI is Redefining Regulatory Excellence
[정부합동] 제3차 실무 마약류대책협의회 개최
UN Multi-Stakeholder Hearing on Pandemic Prevention, Preparedness, and Response (PPPR)
Pharmac to fund medicines used by ambulance providers
[보도참고] 식약처, 혁신 첨단바이오의약품 제품화 지원 위한 ‘바이오챌린저‘ 선정 예정
[보도참고] 식약처, 「마약류관리법」시행령, 시행규칙 개정안 입법예고
M/s. Srikem Laboratories Pvt. Ltd. – Cyclizine ÐÐ and 11 items
[International Certificates] 2026-06-09 00:00:00.0
Brief note on Two Days workshop on Medical Devices Frameworks organized by Danish Medical Agency (DKMA)- CDSCO on 8-9 April 2026
[Medical Devices] 2026-Jun-09
M/s. Srikem Laboratories Pvt. Ltd – Cyclizine ÐÐ and 11 items
[International Certificates] 2026-06-09 00:00:00.0
[보도참고] 식약처, ‘찾아가는 소비자 식의약 안전교실’ 전국 본격 운영
식약처, K-뷰티 할랄 화장품 수출 경쟁력 강화 지원
Crise au Moyen-Orient, un impact sur les prix de production des médicaments
Public Alert No. 030/2026: Alert on the Withdrawal of Levamisole-Containing Medicines as endorsed by the Italian Medicines Agency (AIFA) over serious Neurological risks
Public Alert No. 029/2026 – Recall of Impala Brand Gel Nail Polish Products by Brazilian Health Regulatory Authority(ANVISA)
Public Alert No. 028/2026- Recall Of Children’s Ibuprofen Oral Suspension in the United States Due To Potential Contamination With Foreign Material
Decision: Advertising investigations: May 2026
Geef uw mening over een genetisch gewijzigd geneesmiddel tegen retinoschisis
Pharmaceutical industry’s response to the Ebola Bundibugyo virus disease outbreak
NAFDAC Joins Federal Ministry of Health & Social Welfare, National Food Safety Management Committee and the rest of the world in celebrating World Food Safety Day
Clinical trials for medicines: modifying a clinical trial approval
PMS-Fluconazole 50 mg tablets; Incorrect quantity of tablets
The affected batch may not contain the correct quantity of tablets.
Baxter Corporation products recall; Blue cap breakage
Blue Caps Enhanced Closures (blue tip protectors) may break apart in affected lots.