MedDRA preferred term

Poor quality product administered: adverse event reports recording this term

10,089 reports to FDA record it, 2011–2026; 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.

10,089
reports recording the term: 0.1% of all reports; 1,450
reports, 12 months to June 2026: 1,679 in the 12 months before; 14.7%
marked serious by the reporter: 57.4% across all reports; 0.6%
record death among outcomes, as reported: 9.1% across all reports

10,089 reports in FDA's adverse event database record the MedDRA term "Poor quality product administered": 0.1% of all reports received between October 2011 and June 2026. Coders pick the term that best matches the reporter's description.

1,450 reports recorded it in the 12 months to June 2026, down 14% from 1,679 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, 14.7% are marked serious, 0.6% include death among the outcomes and 4% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Vascepa, BOTOX Cosmetic and Tubersol. 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
Vascepa	—	617	15%
BOTOX Cosmetic	Acetylcholine release inhibitor	422	1.1%
Tubersol	Skin test antigen	405	24.2%
Womens Rogaine Unscented	Arteriolar vasodilator	256	2.2%
Humira	—	254	0%
Testosterone cypionate	Androgen	214	6.9%
Genotropin	—	204	0.5%
Mens Rogaine Extra Strength	—	201	1.6%
MiraLAX	Osmotic laxative	192	0.5%
Levulan Kerastick	—	177	13.2%
Dupixent	Interleukin-4 receptor alpha antagonist	132	0%
Ibrance	Kinase inhibitor	111	0.1%
Paxlovid	—	108	0.2%
Triamcinolone acetonide	Corticosteroid	105	1.1%
Botox	Acetylcholine release inhibitor	87	0.3%
Advil	Nonsteroidal anti-inflammatory drug	85	0.4%
Lantus Solostar	Insulin analog	84	0.2%
Winlevi	Androgen receptor inhibitor	84	6.3%
Progesterone	Progesterone	83	1.5%
Stelara	Interleukin-12 antagonist	74	0.1%
Estradiol	Estrogen	72	0.5%
Lyrica	—	71	0.1%
Asmanex	Corticosteroid	69	1.4%
Latanoprost	Prostaglandin analog	67	0.5%
Tremfya	Interleukin-23 antagonist	65	0.2%

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
Acetylcholine release inhibitor	511	0.6%	0%
Skin test antigen	405	17.2%	12.1%
Nonsteroidal anti-inflammatory drug	333	0.1%	0%
Corticosteroid	330	0%	0%
Androgen	299	1.5%	0%
Arteriolar vasodilator	267	0.6%	0%
Osmotic laxative	238	0.2%	0%
Insulin analog	174	0.1%	0%
Estrogen	160	0.1%	0%
Kinase inhibitor	147	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 20.4%44

2 to 112.6%266

12 to 171.6%166

18 to 448.5%856

45 to 6414.3%1,439

65 to 7410.5%1,055

75 and over8.1%822

Age not given53.9%5,441

Patient sex

Female49.1%4,951

Male29.7%3,001

Not given21.2%2,137

Grey bar: all 20,646,523 reports in the database. 91.6% of these reports give the United States as the country.

Questions about "Poor quality product administered"

What does "Poor quality product administered" 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 poor quality product administered?

10,089 reports through June 2026 (0.1% of all reports), 1,450 of them in the latest 12 months.

Which drugs appear most often in these reports?

Vascepa (617), BOTOX Cosmetic (422), Tubersol (405), Womens Rogaine Unscented (256) and Humira (254). 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.