Recall Flashcards
What are the recall classifications?
Drug Alert: Class 1 - National Patient Safety Alert (equivalent to Class 1 Medicines Recall) – serious patient safety issue
Class 2 – The defect may cause mistreatment or harm to the patient, but it is not life-threatening or serious
Class 3 – The defect is unlikely to cause harm to the patient, and the recall is carried out for other reasons, such as non-compliance with the marketing authorisation or specification.
Drug Alert: Caution in Use, Class 4 - Medicines Notification: Caution in use, Class 4
Company Led Medicines recall - Issued where the licence holder is able to identify the affected customers, therefore it is not necessary to issue an alert to the entire NHS/healthcare system, as the issue is only relevant to a small number of recipients.
For a class 1 recall, at what level do you retrieve your product? E.g. pharmacist level?
Patient level
For a class 2 recall, at what level do you retrieve your product
It depends – mostly pharmacy but possibly patient
What is the timeline to recall product for a class 1 recall?
Immediate
What is the timeline to recall product for a class 2 recall?
48 hours
Where can this information be found?
MHRA website
What does EU DIRECTIVE 2017/1572/EC say about informing the authorities about recall?
In the case of medicinal products, the manufacturer shall implement a system for recording and reviewing complaints together with an effective system for recalling, promptly and at any time, medicinal products in the distribution network. Any complaint concerning a defect shall be recorded and investigated by the manufacturer
What does EU GMP Chapter 8 say about informing the authorities about recall?
All concerned competent authorities should be informed in case of a quality defect:
* Faulty manufacture
* Product deterioration
* Detection of falsification
* Non‐compliance with the marketing authorisation or product specification file
* Or any other serious quality problems with a medicinal or investigational medicinal product which may result in the recall of the product or an abnormal restriction in the Supply
KEY ACTIONS TO BE TAKEN IN THE EVENT OF A RECALL
- In certain cases recall operations may need to be initiated to protect public or animal health prior to establishing the root cause(s) and full extent of the quality defect
- The batch/product distribution records should be readily available with sufficient information on wholesalers and directly supplied customers (with addresses, phone and/or fax numbers inside and outside working hours, batches and amounts delivered)
- Consideration should be given following consultation with the concerned Competent Authorities, as to how far into the distribution network a recall action should extend
- The Competent Authorities should also be informed in situations in which no recall action is being proposed for a defective batch because the batch has expired (such as with short shelf‐life products)
- All concerned Competent Authorities should be informed in advance in cases where products are intended to be recalled. For very serious issues (i.e. those with the potential to seriously impact upon patient or animal health) rapid risk‐reducing actions (such as a product recall) may have to be taken in advance of notifying the Competent Authorities. Wherever possible, attempts should be made to agree these in advance of their execution with the concerned Competent Authorities
- It should also be considered whether the proposed recall action may affect different markets in different ways, and if this is the case, appropriate market‐specific risk‐reducing actions should be developed and discussed with the concerned competent authorities
- Recalled products should be identified and stored separately in a secure area while awaiting a decision on their fate
- The rationale for any decision to rework recalled products should be documented and discussed with the relevant competent authority. The extent of shelf life remaining for any reworked batches that are being considered for placement onto the market should also be considered
RECALL REPORTING REQUIREMENTS
- A formal disposition of all recalled batches should be made and documented
- The progress of the recall process should be recorded until closure and
- A final report issued, including a reconciliation between the delivered and recovered quantities of the concerned products/batches
US – CODE OF FEDERAL REGULATIONS – FIELD ALERT REPORTS (FARS)
- The applicant shall submit information of the following kinds about distributed drug products and articles, to the FDA District Office that is responsible for the facility involved within 3 working days of receipt by the applicant. The information may be provided by telephone or other rapid communication means, with prompt written follow up. The report and its mailing cover should be plainly marked: ‘‘NDA – Field Alert Report’’
(i) Information concerning any incident that causes the drug product or its labelling to be mistaken for, or applied to, another article
(ii) Information concerning any bacteriological contamination, or any significant chemical, physical change or deterioration in the distributed drug product, or any failure of one or more distributed batches
A typical recall procedure would include:
A typical recall procedure would include:
* Quarantine product in stock and in transit as well as work in progress (if not already done)
* Company decision involving senior management and the QP
* Regulatory Authority defect medicines report centre(s) contacted (or other appropriate
authority)
* Distribution records retrieved
* Customers contacted by most appropriate means, or combination of:
➢ First class mail (identifiable envelope)
➢ Telephone
➢ Email
➢ Internet sites
➢ Publications
➢ TV/Radio
* All remaining product quarantined
* Returns procedure implemented/goods collected
* Goods isolated and reconciliation of batches performed
* Investigation undertaken and progress monitored
* Report(s) written
* Review of company procedure carried out and any improvements implemented
What is a class 1 recall
Class I defects are potentially life threatening or could cause a serious risk to health. These must be notified through the Rapid Alert System in all cases.
Examples:
* Wrong product (label and contents are different products)
* Correct product but wrong strength, with serious medical consequences
* Microbial contamination of sterile injectable or ophthalmic product
* Chemical contamination with serious medical consequences
* Mix-up of some products (rogues) with more than one container involved
* Wrong active ingredient in a multi-component product, with serious medical consequences
What is a class 2 recall?
Class II defects could cause illness or mistreatment, but are not Class I. These should be notified through the Rapid Alert System only to Member States and MRA partners to which it is likely or known that the batch has been distributed (including parallel import/distribution).
Examples:
* Mislabelling, e.g. wrong or missing text or figures
* Missing or incorrect information (leaflets or inserts)
* Microbial contamination of non-injectable, non-ophthalmic sterile product with medical consequences
* Chemical/physical contamination (significant impurities, cross-contamination, particulates)
* Mix up of products in containers (rogues)
* Non-compliance with specification (e.g. assay, stability, fill/weight)
* Insecure closure with serious medical consequences (e.g. cytotoxics, child-resistant
containers, potent products)
What is a class 3 recall
Class III defects may not pose a significant hazard to health, but withdrawal may have been initiated for other reasons.
Examples:
* Faulty packaging, e.g. wrong or missing batch number or expiry date Faulty closure
* Contamination, e.g. microbial spoilage, dirt or detritus, particulate matter No times are specified in the EMA guideline, but the UK policy is typical of normal expectations:
* Class I Immediate action including out of hours
* Class II Action within 48 hours
* Class III Action within 5 days
