An urgent recall has been issued for Ipratropium Bromide 500 microgram/2ml Nebuliser Solution by Accord Healthcare Ltd due to incorrect labelling of the product inside the packaging. This alert is critical for clinical, quality, and regulatory professionals managing product compliance and patient safety.
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What changed?
Accord Healthcare Ltd recently identified a critical manufacturing error involving batch Ipratropium Bromide 500 microgram/2ml Nebuliser Solution. An ampoule within the foil pouch was found to carry labelling intended for the Korean market, raising concerns about supply chain management and compliance with market-specific labeling regulations. This labeling discrepancy breaches regulatory standards and poses potential risks, emphasizing the importance of rigorous quality assurance practices.
Who is affected?
Clinical teams administering nebuliser treatments should take immediate heed of this recall. Regulatory professionals responsible for compliance as well as those in quality management overseeing product integrity must also prioritize this announcement. Healthcare providers are urged to review stocks of Ipratropium Bromide and take prompt action to ensure patient safety.
The batch in question could lead to confusion in administration protocols due to non-standard labeling, creating potential risks for patient outcomes, particularly if the labeling may impact dosage recognition or use instructions.
Regulatory response
Root cause analysis
Accord Healthcare Ltd identified non-compliant labeling during routine checks. This error highlights gaps in process controls, specifically in the production line responsible for labeling consistency. Such errors compromise adherence to MDR regulatory frameworks, which require device identification and labeling to align 100% with approved market claims.
Action taken
The manufacturer has initiated a recall procedure under Class 3 guidelines to address this issue. Class 3 recalls pertain to products that are unlikely to cause harm but represent a regulatory or quality concern nonetheless. All affected batches have been identified, and distribution partners have been informed accordingly.
Reporting obligations
Healthcare institutions and professionals are advised to inform their internal pharmacovigilance teams immediately. Reports assessing the impact on patient safety should be directed toward designated regulatory bodies. Accord Healthcare Ltd maintains communication channels for customer feedback and inquiries to ensure transparency throughout the recall process.
FAQ
- What batch is affected by this recall?
The recall applies to a specific batch of Ipratropium Bromide Nebuliser Solution, flagged for incorrect labeling intended for the Korean market. Specific numbers will have been outlined in the official recall notice, which can be accessed using the link below. - Does this labeling error affect patient safety?
While this recall is classified as Class 3—indicating it is unlikely to cause direct patient harm—it could result in administration errors due to labeling confusion. - What steps should healthcare teams take?
Review stock for affected batches, quarantine any identified units, and contact regulatory authorities or Accord Healthcare Ltd for further instructions.
Action summary
Healthcare and regulatory professionals should adhere to the following steps:
- Immediately locate and isolate affected batches.
- Inform relevant quality assurance and risk management teams.
- Follow recall guidelines outlined by Accord Healthcare Ltd.
- Monitor the situation for further updates or guidance on replacement stock.
Disclaimer
This article is intended for clinical, regulatory, and quality assurance teams in the healthcare sector. It is not legal advice. Readers should consult their respective regulatory bodies or legal professionals, as required.
Official announcement
For full information about the announcement, see the link below.