Recall one lot, not everything you sold.
When a supplier recalls a batch, the first question is which customers received it. Without records, the answer is everyone, and you contact every customer you have. With records, it is a list of names you can start working through the same day.
The cost of a recall is the size of the list.
The recall decides who you have to contact. Your records decide how many people that turns out to be, and you pay for every one of them.
Without lot records
You cannot tell which units came from the recalled batch, so you have to assume they all did. That means pulling every order in a date range wide enough to be safe, usually months, and treating all of it as affected.
You refund or replace units that were never at risk. You pay the shipping both ways on them. And you send a safety notice to customers whose product was fine.
With them
You search the lot number and get back the orders it actually shipped on. That is the list, and it is usually a fraction of the one you would have guessed at.
The refunds, the replacements and the return shipping are limited to the units that were really affected. Everyone else never hears about it.
The second cost is harder to put a number on. Every customer you contact remembers that you sold them something that had to be recalled. Contacting ten times more people than you needed to makes a contained problem look like a widespread one.
A list of people, not a number of units.
Recalls start in several places. A supplier recalls a lot. Your own testing finds a problem. A pattern turns up in complaints. A retailer, a distributor or a regulator tells you to. Whoever starts it, they all want the same thing from you, and FDA is the one that writes down exactly what.
Everyone you shipped to
Names, addresses and phone numbers for everyone who received the product, in the US and abroad, with the dates and how many each one got.
21 CFR Part 7
Enough detail to pin down the lot
Products coded well enough to identify one lot exactly, and shipping records kept long enough to find it. That means longer than the product stays on a shelf and in use.
21 CFR Part 7 · Part 806
Proof that you reached them
Sending the notice is not enough. You have to show who you contacted and when. That is a second record, and you build it from the first one.
21 CFR Part 7
You search the lot number, and we build the list.
Pick a lot, a serial number, a GTIN, an expiry range or a date range. SerialTrack builds the report in the background and fills in the customer details from your fulfillment system as it goes. You get the name, email address and shipping address for every order that lot went out on.
It comes out as a table on screen and a CSV to download. Support works the list from the CSV, and the same file shows FDA who you contacted.
Recalls are called on lots. So lots have to be on the record.
A serial number alone will not help you here. You need the lot number recorded against each order. If your stock has a 2D UDI barcode on it, one scan captures the GTIN, the lot, the expiry and the serial together. So the lot is on the record when you need to search on it.
Scan what is on the box
The 2D barcode already printed on regulated stock holds every element at once.
Stored element by element
Lot, expiry and serial are kept as separate values, each searchable on its own.
Report on any of them
A recall on a lot, a warranty question on a serial number, a shelf-life check on an expiry range.
In the middle of one right now?
If you are working a live recall and need the list in a particular format, or need help getting past shipments loaded in, tell us what you are dealing with. We would rather help you through it first.
Get in touchStart recording on the next shipment.
Connect your store, scan one order, and look at the record. About five minutes to set up, and nothing to pay for thirty days.