Received Jun 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TBE | TICK-BORNE ENCEPH (TICOVAC) | PFIZER\WYETH | UNK | 000690029702 | — |
Describe Event, Problem or Product Use Error: Source: Unified Intake Tool | Manufacturers are not required to report all NDC numbers to the FDA, or drug data vendors like (name withheld) or (name withheld) data bank. The NDC on the syringe in the attached photo was not recognized by this reporting system, even though it is clearly the NDC on the product used by the healthcare worker. Not having all NDCs reported creates issues in electronic healthcare systems (EHR). Medications cannot be scanned during administration, or preparation (an important step in a safe med delivery system), so documentation cannot be completed accurately. Not reporting the "inner" NDC is very common. Manufacturers frequently report the "outer" NDC, the one on the box, but do not report the inner NDCs. If they have more than one box size, say a box with one syringe, and a box with 10 syringes, both the box (outer) NDCs will be reported, but frequently the inner, or syringe NDC will not be reported. NDCs which are not reported must be manually entered into the EHR at each individual healthcare organization which uses that product or will not scan in the system. This leaves open the possibility of error across all of these organizations. The fix would be very simple. Require the manufacturers to report all NDCs, not just the NDCs on the outer box. This would be almost no extra work for the manufacturer, as they already report some NDCs. They could just report all of them. On the healthcare organization side it would save many hours of data entry manually entering NDCs. It would add a level of patient safety by the manual entry of these NDCs by all the healthcare organization across the country. In the picture I provided the box has a NDC of 0069-0297-02. This NDC is reported by the manufacturer. This reporting system recognized that NDC. The syringe which was contained inside the box has an NDC of 0069-0297-01. This NDC was not reported by the manufacturer and was not recognized by this reporting system. If I only had the syringe NDC I would not have been able to start this report, since a NDC recognized by this reporting system is required if you select NDC. Please consider requiring manufacturers to report all NDCs. It would be no extra burden on the manufacturer, but living in the age of the EHR, it would provide a meaningful benefit to all healthcare organizations which use these products.