Safety · Field actions

Recalls and field actions

This register exists whether or not there is anything in it. A recall page that appears only when there is bad news is not a register, it is publicity control. Ergopharm keeps a standing page listing every field action we have initiated, open or closed, so that a distributor, pharmacist or authority can check the status of a batch at any hour without having to ask us first. An open action appears at the top of this page with its batch data, the markets involved, the depth and the current status; a closed one stays in the archive below, permanently. The three-class scheme used here is the one generally applied to recalls — roman numerals in the United States under 21 CFR Part 7, arabic numerals in the European rapid alert system for quality defects, with equivalent meaning. Each market's authority classifies an action in its own territory; we state our own classification, consistently, at initiation.

Status as at 6 August 2026: no recalls or field actions are currently open, and none has been initiated. The archive below is empty. This statement is reviewed at every management review and is updated the same day any field action is initiated. If you are holding stock and want the status of a specific batch, write to quality@ergopharm.net quoting the product, LOT and EXP as printed on the carton, and we will answer whether or not there is anything to report.

Classification by risk, and depth of recall

Class I: A defect presenting a life-threatening or serious risk to health — wrong product, wrong active substance, wrong strength, a failure of sterility assurance, or a labelling error capable of causing serious harm. Communicated urgently and normally taken to patient level.
Class II: A defect that may cause harm or mistreatment but is neither life-threatening nor serious — an out-of-specification result on a non-critical attribute, a closure or seal defect, a missing or incorrect leaflet, a stability signal short of failure. Usually taken to pharmacy level.
Class III: A defect unlikely to cause harm, where the action is taken for other reasons — a printing or minor labelling non-conformity, a documentation or specification deviation with no patient impact. Usually taken to wholesale level, or handled as a withdrawal of remaining stock.
Depth — wholesale level: The action stops at importers, licence-holders and wholesalers. Stock is quarantined in their warehouses and in transit; packs already dispensed remain with patients.
Depth — pharmacy / dispensing level: Extends to pharmacies, hospital pharmacies and dispensing clinics — every point that still holds saleable stock must quarantine, count and reconcile it.
Depth — patient / user level: Extends to the person holding the pack and requires public communication in each market. Reserved for defects capable of serious harm; the decision explicitly weighs the harm from the defect against the harm of interrupting supply of the medicine, and is recorded either way.

Recall, field safety notice, stock recovery — what differs

Recall: Removal or correction of packs that have already left our control, because they are defective or may be. It carries a class, a depth, a reconciliation target and an effectiveness check, is notified to partners, and reaches each market's authority through the local licence-holder or importer.
Field safety notice: A written communication to users about action being taken in the field. The term belongs to medical devices, where a field safety corrective action is announced by a field safety notice under Regulation (EU) 2017/745; the equivalent for medicines is a direct communication to healthcare professionals. We use it for corrective information that does not require packs to move — an amended handling or storage instruction, a clarified reconstitution or injection-site statement.
Stock recovery: Retrieval of product that has not left our control — still in our own warehouse, or in transit and not yet accepted by the consignee. It is not a recall, is not classified and is not notified externally, but it is recorded as a deviation, investigated and trended alongside the rest.
Market withdrawal: Removal of stock for a reason that is not a quality defect — a discontinued presentation, a pack-size change, an expiry-management decision. Recorded separately and never described, in either direction, as a recall.

How a field action is decided

01
Signal
A complaint from the field, a confirmed out-of-specification result, an ongoing-stability failure, a deviation surfaced during batch record review, a returned-goods finding, or information from a partner or an authority. Any of these opens a potential-field-action file. The file is opened on suspicion, not on proof.
02
Health-hazard evaluation
A cross-functional assessment — quality assurance, production, analytical development and medical — of what the defect can actually do: its nature and likely frequency, the population exposed, the doses already administered, the reversibility of any harm, and the availability of alternative supply. Conducted under the quality risk management principles of ICH Q9(R1) and written down and signed whatever the conclusion.
03
Decision
The decision to initiate a field action, and its class and depth, is taken by the head of Quality Assurance together with the authorised person responsible for batch release. It cannot be overruled by commercial or production functions. A decision not to act is documented to the same standard as a decision to act, with the reasoning, the data relied on and the signatures.
04
Distribution reconstruction
Distribution records, dispatch documentation and the serialisation and EPCIS event data identify every consignment of the affected LOT — which market, which partner, what quantity, shipped when — together with what remains in our own quarantine and what was destroyed before dispatch. The reconstruction is complete before notification goes out, so that nobody is asked to search for stock they never received.
05
Notification
Partners are notified in writing within 24 hours of the decision for a Class I action and within 3 working days otherwise, by email to the named recall contact with telephone confirmation of receipt. The notice states the product, LOT and EXP, the defect, the class, the depth, the action required and the response date. In each market the local licence-holder or importer notifies its own competent authority under that market's procedure and timelines; we supply the batch data, the evaluation and the text they need to do it.
06
Retrieval and reconciliation
Partners quarantine, count and report. We reconcile quantity shipped against quantity accounted for — returned, destroyed under certificate, or dispensed and unrecoverable — and pursue the difference until the account balances or the residual is explained in writing. The reconciliation is part of the record, not an internal note.
07
Effectiveness check and closure
A defined sample of notified partners is contacted to confirm that the notice was received, understood and acted on, and that no affected stock remains available for supply. The action closes with a written report covering root cause, reconciliation, effectiveness check, corrective and preventive action and the verification of that action. The entry then stays in the archive with the status Closed and the closure date.

What a partner must do on receiving a recall notice

Acknowledge receipt the same working day to the address given in the notice. Silence is treated as non-receipt and we will telephone.
Stop supply of the named LOT immediately — including picking lists, back orders, consignment stock and anything already staged for dispatch.
Segregate the stock physically, label it clearly as recalled and not for supply, and block it in the inventory system as well as on the shelf. A shelf label alone does not stop an automated picker.
Count what is held and reconcile it against what was received and what was supplied onward, consignment by consignment.
Pass the notice down your own chain to the depth stated — sub-distributors, pharmacies, hospitals, clinics — and collect their acknowledgements rather than assuming them.
If you are the licence-holder or importer in your market, notify your competent authority under your national procedure and send us a copy of the notification and of any subsequent correspondence.
Return the response form by the date in the notice, giving quantities held, supplied onward and recovered. Hold the stock until we confirm return or destruction in writing; destroy only on written instruction and send us the destruction certificate.

Archive — column shape

Date: Date the field action was initiated, written as YYYY-MM-DD. Not the date of the signal and not the date of closure — both of those appear inside the entry.
Product: Product name and strength exactly as printed on the carton, with the monograph number it carries in the register, linked to its datasheet.
LOT / EXP: Batch number and expiry as printed on the pack — for example TE2509A · 06 / 2029. Where more than one batch is affected each is listed individually; batches are never expressed as a range.
Markets: Destination markets the affected batch was shipped to, by country. A market appearing here means stock was sent there, not that any is still held.
Depth: Wholesale, pharmacy or patient level as decided at initiation. If the depth was extended after initiation, both the original and the extended depth are shown, each with its date.
Class: I, II or III as classified by Ergopharm quality assurance at initiation, with any subsequent reclassification shown alongside rather than overwriting it.
Status: Open · In reconciliation · Effectiveness check · Closed, with the closure date and a link to the summary report. Closed entries are never removed and never edited silently; the register is cumulative.
Empty state: With no entries the table still renders its header row and a single line beneath it: no field actions recorded. The columns above are the shape any future entry will take.