MedDRA preferred term

Intercepted product preparation error: adverse event reports recording this term

12,019 reports to FDA record it, 2017–2026; 0.1% of the database.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

12,019
reports recording the term: 0.1% of all reports; 1,007
reports, 12 months to June 2026: 2,278 in the 12 months before; 0.6%
marked serious by the reporter: 57.4% across all reports; 0.1%
record death among outcomes, as reported: 9.1% across all reports

12,019 reports in FDA's adverse event database record the MedDRA term "Intercepted product preparation error": 0.1% of all reports received between June 2017 and June 2026. Coders pick the term that best matches the reporter's description.

1,007 reports recorded it in the 12 months to June 2026, down 56% from 2,278 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Of reports recording this term, 0.6% are marked serious, 0.1% include death among the outcomes and 0.1% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Eligard, Device and Neulasta. That order mostly follows how many reports each drug has overall; the table also gives the term's share within each drug's own reports. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Drugs listed as suspect products in these reports

Drug	Class	Reports with this term	Share of the drug's own reports
Eligard	Gonadotropin releasing hormone receptor agonist	9,024	20.3%
Device	—	1,624	32.1%
Neulasta	Leukocyte growth factor	1,572	2%
Kyprolis	Proteasome inhibitor	366	3.2%
Fensolvi	Gonadotropin releasing hormone receptor agonist	198	26.5%
Blincyto	—	110	1.7%
Mvasi	Vascular endothelial growth factor inhibitor	54	1.2%
Nplate	Thrombopoietin receptor agonist	48	0.4%
Kanjinti	HER2/neu receptor antagonist	41	2.9%
Eylea	Vascular endothelial growth factor inhibitor	27	0.1%
Actemra	Interleukin-6 receptor antagonist	26	0%
Remicade	Tumor necrosis factor blocker	19	0%
Orencia	Selective T cell costimulation modulator	18	0%
Riabni	CD20-directed cytolytic antibody	16	4.3%
Benlysta	B lymphocyte stimulator-specific inhibitor	14	0.1%
Izervay	Complement inhibitor	14	5.5%
Nucala	Interleukin-5 antagonist	14	0%
Ocrevus	CD20-directed cytolytic antibody	13	0%
Vectibix	Epidermal growth factor receptor antagonist	12	0.1%
Eylea Hd	Vascular endothelial growth factor inhibitor	10	0.9%
Herceptin	HER2/neu receptor antagonist	10	0%
Rituxan	CD20-directed cytolytic antibody	10	0%
Casirivimab Imdevimab	—	9	0.5%
Onpattro	Small interfering RNA	9	0.3%
Xolair	Anti-IgE	9	0%

Drugs with a page on this site, ordered by the number of their reports recording this term. The last column is the term's share within that drug's own reports, against 0.1% across the whole database. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

By pharmacologic class

Class	Reports with this term	Share of class reports	Median drug in class
Gonadotropin releasing hormone receptor agonist	9,225	15%	0%
Leukocyte growth factor	1,574	1.4%	0%
Proteasome inhibitor	366	0.3%	0%
Vascular endothelial growth factor inhibitor	100	0.1%	0%
HER2/neu receptor antagonist	53	0.1%	0%
Thrombopoietin receptor agonist	48	0.1%	0%
Tumor necrosis factor blocker	36	0%	0%
CD20-directed cytolytic antibody	29	0%	0%
Interleukin-6 receptor antagonist	26	0%	0%
Selective T cell costimulation modulator	18	0%	0%

Classes ordered by count. Class shares follow the class's overall report volume as much as anything else.

Patients in these reports

Patient age

Under 20%6

2 to 111.3%157

12 to 170.4%46

18 to 441.7%210

45 to 649.9%1,193

65 to 7418.3%2,202

75 and over24%2,879

Age not given44.3%5,326

Patient sex

Female11.5%1,383

Male61.1%7,340

Not given27.4%3,296

Grey bar: all 20,646,523 reports in the database. 71.4% of these reports give the United States as the country.

Questions about "Intercepted product preparation error"

What does "Intercepted product preparation error" mean in an adverse event report?

It is a MedDRA preferred term, the dictionary FDA uses to code what a reporter described. The report's own description is not published by openFDA and is not shown here.

How many reports record intercepted product preparation error?

12,019 reports through June 2026 (0.1% of all reports), 1,007 of them in the latest 12 months.

Which drugs appear most often in these reports?

Eligard (9,024), Device (1,624), Neulasta (1,572), Kyprolis (366) and Fensolvi (198). Drugs with many reports overall lead almost every term's list. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Does a drug appearing here mean it was responsible for this reaction?

No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

I have this symptom. What should I do?

This site cannot assess anyone. A pharmacist or clinician can; for an emergency, call the local emergency number. Nothing on this page is medical advice.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. Terms are pooled across spelling and capitalisation variants of one MedDRA preferred term. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.