Violation Code: 342
FDA Violation
Charge Code: PERSONALRX
Violation Details
- Violation Code (ASC ID)
- 342
- Charge Code
- PERSONALRX
- Description
- The article appears to be a drug which requires a prescription from your doctor.
- Legal Section
- 502(a) & (f)(1), 801(a)(3); MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Schering Plough S.A. | Rio De Janerio, BRAZIL | 15 |
| 2 | Blue Wings | Kwai Chung, HONG KONG | 14 |
| 3 | Bora Pharmaceutical Services Inc. | Mississauga, CANADA | 12 |
| 4 | Allergan Pharmaceuticals Ireland | Westport, IRELAND | 11 |
| 5 | Prollenium Medical Technologies Inc. | Aurora, CANADA | 4 |
| 6 | FITOLAB | Quito, ECUADOR | 3 |
| 7 | Diennett Pharmacy | Beverly Hills, UNITED STA | 3 |
| 8 | Janssen Inc. | North York, CANADA | 3 |
| 9 | Lilly Pharmaeutical | Giesen, GERMANY | 3 |
| 10 | Pfizer Ag | Zurich, SWITZERLAN | 3 |
| 11 | Novartis Pharma Schweiz Ag | Rotkreuz, NETHERLAND | 2 |
| 12 | Baxter Corporation | Mississauga, CANADA | 2 |
| 13 | Sanofi Aventis | Vernier, SWITZERLAN | 2 |
| 14 | CENTRALE FILLERS | Montpellier, FRANCE | 2 |
| 15 | Faracia Gran Rosso | Buenos Aires, ARGENTINA | 2 |
| 16 | Joe Familar | Zamboanga City, PHILIPPINE | 2 |
| 17 | Glaxo Smith Kline | Riyadhriyadh, SAUDI ARAB | 2 |
| 18 | Mbe Robina | Robina, AUSTRALIA | 2 |
| 19 | Apotex Inc. | North York, CANADA | 2 |
| 20 | JAMES BROWN PHARMA | Quito, ECUADOR | 2 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 4/11/2025 | IVERMECTIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL) 62LCY47 | Merck, Inc.UNITED STA |
| 2/21/2025 | NUTRIENT/TONIC N.E.C. 65CDN99 | Baxter CorporationCANADA |
| 12/11/2024 | SODIUM CHLORIDE (REPLENISHER) 65RCK19 | Baxter CorporationCANADA |
| 12/11/2024 | SODIUM CHLORIDE (REPLENISHER) 65RCK19 | Baxter CorporationCANADA |
| 11/22/2023 | OTHER SKIN CARE PREPARATIONS, N.E.C. 53LY99 | CENTRALE FILLERSFRANCE |
| 11/22/2023 | OTHER SKIN CARE PREPARATIONS, N.E.C. 53LY99 | CENTRALE FILLERSFRANCE |
| 10/12/2023 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VLA99 | |
| 4/13/2023 | BOTOX 65QIL02 | |
| 4/11/2023 | BOTOX 65QCY02 | Blue WingsHONG KONG |
| 4/11/2023 | BOTOX 65QCY02 | Blue WingsHONG KONG |
| 4/11/2023 | BOTOX 65QDR02 | Blue WingsHONG KONG |
| 4/11/2023 | BOTOX 65QCY02 | Blue WingsHONG KONG |
| 4/11/2023 | BOTOX 65QCY02 | Blue WingsHONG KONG |
| 4/11/2023 | BOTOX 65QCY02 | Blue WingsHONG KONG |
| 4/11/2023 | BOTOX 65QCY02 | Blue WingsHONG KONG |
Related Violations
Other violations under the same legal section: 502(a) & (f)(1), 801(a)(3); MISBRANDING
Frequently Asked Questions
What is FDA violation code 342?
342 is an FDA violation code that indicates: "The article appears to be a drug which requires a prescription from your doctor.". This violation is based on 502(a) & (f)(1), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 342?
According to FDA Import Refusal data, there have been 235 import refusals issued for violation code 342, affecting 164 unique firms.
When was the most recent refusal for violation 342?
The most recent import refusal for violation 342 was on April 11, 2025.
What products are commonly refused for violation 342?
Products commonly refused under violation 342 include: IVERMECTIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL), NUTRIENT/TONIC N.E.C., SODIUM CHLORIDE (REPLENISHER), OTHER SKIN CARE PREPARATIONS, N.E.C.. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 342?
Violation code 342 is based on 502(a) & (f)(1), 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.