Report a quality defect or suspect pack

Before you report

• Stop using the pack. Do not administer, dispense or sell from it, and do not put it back into saleable stock.
• Retain everything — the ampoules or blisters, the outer carton, the leaflet, the tamper-evident seal and, if you have it, the shipper carton. The carton carries the LOT, EXP, GTIN and serial that let us find the batch record; without them an investigation has nowhere to start.
• Photograph the pack before anything moves: every face of the carton, the panel carrying LOT and EXP, the DataMatrix, the scratch-off verification panel, and the defect itself — in focus, in good light, with something for scale.
• Do not return the pack and do not destroy it unless we or your supplier ask you to. An unsolicited return posted in an ordinary envelope normally arrives too damaged to be evidence, and moving a suspect pack across a border without agreement creates problems of its own.
• Note where the pack was obtained — pharmacy, hospital, wholesaler or distributor, town and country — and the date, and keep the invoice or dispensing record if one exists.
• Store the retained pack as its label directs, below 25 °C and out of light, and keep it out of the reach of children. If you suspect falsification, keep it physically separate from saleable stock and mark it clearly: quarantine, do not supply.
• If someone has taken a dose from the pack and is unwell, clinical care comes first. Contact a physician, then report the suspected reaction to pv@ergopharm.net and to your national reporting scheme — that route is separate from this one, and both can run in parallel.

What counts as a quality defect

• Visible defect in the container — chipped, cracked or scored ampoule glass, a mis-formed or badly scored neck, a blister cavity that is split, unsealed or perforated.
• Container damage found on receipt — broken ampoules in the tray, a crushed, stained or wet carton, a shipper that has been opened in transit.
• Particulate matter — any visible particle, fibre, glass fragment or precipitate in the solution. An oil solution is denser and more viscous than an aqueous one and may pour slowly in a cold room; that is normal. Visible particles are not.
• Discoloration or change in appearance — a solution that has darkened, clouded or separated, tablets that have mottled, spotted, chipped, cracked or changed colour.
• Sealing or closure fault — a tamper-evident seal already broken, a carton that opens without breaking the seal, an ampoule that has leaked, an ampoule visibly under- or over-filled against the others in the tray.
• Labelling error — wrong name, strength or pack size; LOT or EXP missing, illegible, or not matching between carton, ampoule and leaflet; a DataMatrix that will not scan; a missing, wrong or wrongly folded leaflet.
• Shortfall or wrong contents — fewer ampoules or tablets than the carton states, a missing tray or insert, contents that do not correspond to the carton.
• Suspected tampering or falsification — a carton that looks re-glued, over-labelled or reprinted, a scratch panel already removed, typography, colour, varnish or print quality that differs from packs you have handled before, or a pack obtained outside the legitimate supply chain.

What Ergopharm does with the report

1. 01

   Logged

   Every report is entered in the complaints register within one working day and given a reference number, which we email back to you. Suspected falsification and any report suggesting a risk to patients are triaged the same working day.

2. 02

   Triaged and classified

   QA classifies the report as critical, major or other, records whether the defect is confirmed or suspected, and asks the question that matters most at this stage: could the same cause affect other packs of the same batch, or other batches? Risk assessment follows the quality risk management principles of ICH Q9(R1).

3. 03

   Investigated against the batch record

   We retrieve the manufacturing and packaging records for that LOT — in-process and release data, environmental monitoring for the fill session, sterilisation and filtration records, line clearance and reconciliation, and the printing and serialisation logs. The retained samples of the batch are examined and, where the defect can be tested for, re-tested against specification by the same validated methods used at release.

4. 04

   Root cause and health-hazard evaluation

   Where the pack can be returned safely we examine it directly. Root cause analysis addresses both the defect and the escape — how it passed the controls that should have caught it — and a health-hazard evaluation asks what harm the defect could do to a patient who used the pack. Corrective and preventive action is raised against the root cause, not the symptom, and is verified for effectiveness before the file closes.

5. 05

   Feedback to the reporter

   We aim to acknowledge within 2 working days, give a first substantive response within 10 working days, and close the investigation within 30 calendar days. Where a full investigation needs longer — stability re-testing, for instance, cannot be hurried — we say so and give a date. You are told the conclusion and what changed as a result.

6. 06

   Trended, and escalated where warranted

   Every complaint feeds the periodic product quality review, trended by product, by defect type and by packaging line. A rising signal is investigated even when each individual report is minor. Where the health-hazard evaluation shows a risk to patients, or a batch is confirmed outside specification, the complaint escalates to a field action under the process set out on the recalls page.

A code that will not verify is usually not a falsified pack

Most failed checks on /verify have an ordinary explanation, and it is worth ruling those out before drawing a conclusion. The code was mistyped — 0 and O, 1 and I, 5 and S account for most of it. The scratch panel was rubbed too hard and a character came away with the coating. The code had already been checked, by the pharmacy at dispensing or by an earlier holder of the pack, and a verification code is designed to report itself as spent once used. Or the carton is genuine and the panel was damaged in transit. A failed check is a reason to ask us, not a finding in itself. Send the report regardless: from the LOT and the serial we can tell whether the pack belongs to a batch we made and shipped, and if it does not, that is precisely what we need to know quickly.

Why suspect packs are handled separately

Falsified medicines are a supply-chain problem, and the legal frameworks place duties on whoever is holding the pack, not only on the manufacturer. In the European Union, Directive 2011/62/EU and Commission Delegated Regulation (EU) 2016/161 require prescription packs to carry a unique identifier and an anti-tampering device and to be verified and decommissioned at the point of dispensing; where the packaging appears to have been tampered with, or verification indicates the product may not be authentic, the person holding it must not supply it and must inform the competent authority immediately (Article 30). In the United States the Drug Supply Chain Security Act sets out how suspect product is quarantined and investigated, and requires notification of FDA and of immediate trading partners, on Form FDA 3911, within 24 hours of a determination that product is illegitimate. Ergopharm serialises every saleable carton to the GS1 General Specifications and supports these checks with batch and serial data, but nothing on this page replaces those obligations: if you are a wholesaler, pharmacy or dispenser, follow your own market's procedure first and copy your report to us.