What a lot number is and where to find it
The lot (batch) number identifies the production run a product comes from. It is printed on the box and on the syringe or vial, next to the expiry date, usually marked LOT. Most filler manufacturers also include peel-off labels or an implant card with the product name and lot, so the details can go into the patient's record without retyping.
A product name alone is not enough. If a manufacturer finds a problem, it is almost always limited to particular batches, and only the patients who received those batches need to be contacted.
Why recording it matters
Botulinum toxin products are biological medicines. Their summary of product characteristics states that, to improve the traceability of biological medicines, the name and batch number of the administered product should be clearly recorded. National medicines agencies, such as HALMED in Croatia, follow suspected adverse reactions to biological medicines by brand name and batch number, and healthcare professionals are among those required to report them.
Dermal fillers fall under the EU Medical Device Regulation (MDR, Regulation (EU) 2017/745). Fillers injected for purely aesthetic purposes are covered too, through Annex XVI. Fillers that remain in the body and are wholly or mainly absorbed, such as hyaluronic acid fillers, are implantable devices in class III, the highest risk class.
For class III implantable devices, the MDR requires health institutions to store the device's unique device identifier (UDI), preferably electronically (Article 27(9)). Manufacturers of implantable devices supply an implant card with the device's name, lot or serial number and UDI, and Member States must require health institutions to give it to the patient together with the institution's details (Article 18).
What to record for every treatment
- Patient and date of treatment
- Practitioner who performed the treatment
- Product by brand name (not just "hyaluronic acid" or "toxin")
- Lot number and expiry date
- Quantity used, in ml or units
- Treated areas or injection points
- Implant card or label: whether it was given to the patient
If one syringe is split across several areas, or two different batches are used in one session, record which batch went where. That is exactly the question you will be asked if a reaction appears in one area.
When something goes wrong
Adverse reaction: when a patient reports a reaction, the report to the medicines agency asks for the brand name and batch number. If the batch was never recorded, the report goes in as "unknown", and the link to the batch is lost for good.
Recall or field safety notice: when a manufacturer or distributor recalls a batch, the clinic has to answer one question: which of our patients received this lot? With paper records, that means going through every chart since the batch arrived. With searchable records, it is a filter.
Paper, spreadsheet or software
- Paper charts with stuck-on labels keep the information, but you cannot search them. A recall means opening every chart.
- A spreadsheet can be searched, but it lives apart from the patient record and the stock. Every lot is copied by hand, and typos are common.
- Clinic software that links the product, lot and stock to the treatment record takes the lot straight from stock, so it is written once and stays searchable.
How Injectly handles it
In Injectly, every product in stock is kept by batch, with its lot number and expiry date. During a treatment, the practitioner picks the product and batch for each area on the face map, and the quantity is deducted from stock automatically. Batches that are close to expiry are flagged on the dashboard.
The lot stays in the treatment record and in the summary the patient receives after the visit, and stock documents (receipts, issues, stocktakes) can be exported for your accountant.
Frequently asked questions
Do I have to record the batch number of botulinum toxin?
Botulinum toxin is a biological medicine, and its product information states that the name and batch number of the administered product should be clearly recorded for traceability. Adverse reactions to biological medicines are followed by brand name and batch number.
Does this also apply to fillers used for aesthetic purposes?
Yes. Under the EU MDR, dermal fillers are regulated as medical devices even when they are used purely for aesthetic purposes (Annex XVI). Resorbable fillers such as hyaluronic acid are class III implantable devices, the highest risk class.
What is an implant card and do I have to give it to the patient?
An implant card is supplied by the manufacturer with an implantable device and carries the device name, lot or serial number and UDI. Under Article 18 of the MDR, Member States require health institutions to make it available to the patient, together with the institution's details. Check the manufacturer's instructions for your product.
What if the lot was not recorded and the patient has a reaction?
Report the suspected reaction anyway. Reporting forms let you mark the batch number as unknown. The report still counts, but it can no longer be linked to a batch, which is why the lot should be written down at the time of treatment.
Where do I find the lot number?
On the outer box and on the syringe or vial, usually next to the expiry date and marked LOT. Many filler manufacturers also include peel-off labels or an implant card with the lot printed on them.
Sources
- Regulation (EU) 2017/745 on medical devices (MDR), Articles 2, 18, 27 and Annexes VIII, XVI
- MDCG 2019-8 v2: Guidance on the implant card (Article 18 MDR)
- HALMED: Biological and biosimilar medicines (traceability by brand name and batch)
- HALMED: How to report a suspected adverse reaction
See it in your clinic
Book a short demo and we will show you how lots, stock and treatment records connect in Injectly.
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