Violation Code: 3500
FDA Violation
Charge Code: RXLABEL
Violation Details
- Violation Code (ASC ID)
- 3500
- Charge Code
- RXLABEL
- Description
- The labeling fails to bear, at a minimum, the symbol "RX Only".
- Legal Section
- 503(b)(4)(A), 801(a)(3); MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | A.H. GEIGER | Lorrach, GERMANY | 25 |
| 2 | Laboratorium Soluna Heilmittel Gmbh | Donauworth, GERMANY | 16 |
| 3 | Similasan AG | Jonen, SWITZERLAN | 10 |
| 4 | Fabricado Por Laboratorios Feltrex, S.A. | Santo Domingo De Guzman, DOMINICAN | 3 |
| 5 | W. Last CC | Johannesburg, SOUTH AFRI | 3 |
| 6 | H Cosmetiques Ci | Milan, ITALY | 2 |
| 7 | Pekana Naturheilmittel GmbH | Kislegg, GERMANY | 2 |
| 8 | MCA Medical And Chemical Agency S.R.L. | San Vittore Olona, ITALY | 2 |
| 9 | Biologische Heilmittel Heel Gmbh | Baden-Baden, GERMANY | 2 |
| 10 | Novo Nordisk A/S | Bagsvard, DENMARK | 2 |
| 11 | Daejin Chemical Co Ltd | Kyunggi Do, SOUTH KORE | 1 |
| 12 | Excyton-Excymer Gmbh | Engelberg, SWITZERLAN | 1 |
| 13 | Farma Quimia S.A. de C.V. | Cuautitlan Izcalli, MEXICO | 1 |
| 14 | FATIH SULTAN MEHMET CAD | Istanbul, TURKEY | 1 |
| 15 | BOEHRINGER INGELHEIM FOR NOVO NO | Bagsvard, DENMARK | 1 |
| 16 | Allergan Medical | Irvine, UNITED STA | 1 |
| 17 | Essence Master Limited | Hong Kong, HONG KONG | 1 |
| 18 | Jsc Technolg | Uman, UKRAINE | 1 |
| 19 | Esapharma SpA | Melzo, ITALY | 1 |
| 20 | H Cosmetiques CI | Abidjan, IVORY COAS | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 10/14/2025 | SEMAGLUTIDE (ANTI-DIABETIC) 61PDY72 | |
| 10/1/2025 | SEMAGLUTIDE (ANTI-DIABETIC) 61PCY72 | Novo Nordisk A/SDENMARK |
| 10/1/2025 | TIRZEPATIDE (ANTI-DIABETIC) 61PCY74 | ELI LILLY NEDERLAND B.V.NETHERLAND |
| 10/1/2025 | IVERMECTIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL) 62LCA47 | |
| 7/8/2025 | SEMAGLUTIDE (ANTI-DIABETIC) 61PCP72 | Novo Nordisk A/SDENMARK |
| 6/16/2025 | METFORMIN (ANTI-DIABETIC) 61PCY26 | USV Private LimitedINDIA |
| 6/5/2025 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VCY99 | A.H. GEIGERGERMANY |
| 5/21/2025 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VCY99 | A.H. GEIGERGERMANY |
| 5/21/2025 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VCY99 | A.H. GEIGERGERMANY |
| 5/21/2025 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VCY99 | A.H. GEIGERGERMANY |
| 5/21/2025 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VCY99 | A.H. GEIGERGERMANY |
| 5/21/2025 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VCY99 | A.H. GEIGERGERMANY |
| 5/21/2025 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VCY99 | A.H. GEIGERGERMANY |
| 5/21/2025 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VCY99 | A.H. GEIGERGERMANY |
| 5/20/2025 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VCY99 | A.H. GEIGERGERMANY |
Frequently Asked Questions
What is FDA violation code 3500?
3500 is an FDA violation code that indicates: "The labeling fails to bear, at a minimum, the symbol "RX Only".". This violation is based on 503(b)(4)(A), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3500?
According to FDA Import Refusal data, there have been 104 import refusals issued for violation code 3500, affecting 47 unique firms.
When was the most recent refusal for violation 3500?
The most recent import refusal for violation 3500 was on October 14, 2025.
What products are commonly refused for violation 3500?
Products commonly refused under violation 3500 include: SEMAGLUTIDE (ANTI-DIABETIC), TIRZEPATIDE (ANTI-DIABETIC), IVERMECTIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3500?
Violation code 3500 is based on 503(b)(4)(A), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This section of the law establishes requirements that imported products must meet to be allowed entry into the United States.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.