Violation Code: 2880
FDA Violation
Charge Code: RXCOMPOUND
Violation Details
- Violation Code (ASC ID)
- 2880
- Charge Code
- RXCOMPOUND
- Description
- the labeling fails to bear, at a minimum, the symbol "Rx only."
- Legal Section
- 503(b)(4)(A) & 502(c), 801(a)(3); MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | FITOLAB | Quito, ECUADOR | 3 |
| 2 | Erregierre S.p.A. | San Paolo d'Argon, ITALY | 2 |
| 3 | Access Animal Health Agencies Pty Ltd | Roseville, AUSTRALIA | 2 |
| 4 | Zhengzhou Minzhong Pharmaceutical Co., Ltd. | Zhengzhou, CHINA | 2 |
| 5 | DREAM COSMETICS | Abigian, IVORY COAS | 2 |
| 6 | B.M.P. Bulk Medicines & Pharmaceuticals GmbH | Norderstedt, GERMANY | 1 |
| 7 | Jiangsu Jiaerke Pharmaceuticals Group Corp., Ltd. | Changzhou, CHINA | 1 |
| 8 | W. Last CC | Johannesburg, SOUTH AFRI | 1 |
| 9 | Bayer AG | Berlin, GERMANY | 1 |
| 10 | Prudential Pharmaceuticals Ltd | Nedak Dist, INDIA | 1 |
| 11 | Piramal Healthcare (Canada) Ltd. | Aurora, CANADA | 1 |
| 12 | Teva Pharmaceutical Industries, LTD. | Petakh Tikva, ISRAEL | 1 |
| 13 | Global Bulk Drugs & Fine Chemicals | Hyderabad, INDIA | 1 |
| 14 | Huzhou Foreign Trade Company Ltd. | Zhejiang, CHINA | 1 |
| 15 | Zhejiang Ruibang Laboratories Co., Ltd | Wenzhou, CHINA | 1 |
| 16 | Shalina Laboratories Limited | Mumbai, INDIA | 1 |
| 17 | Aarti Drugs Limited | Tarapur, INDIA | 1 |
| 18 | Xellia Pharmaceuticals ApS | Copenhagen S, DENMARK | 1 |
| 19 | Yick-Vic Chemicals & Pharmaceuticals (HK) LTD | Kwun Tong, HONG KONG | 1 |
| 20 | Biotika a.s. | Slovenska Lupca, SLOVAKIA | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 10/25/2024 | TIRZEPATIDE (ANTI-DIABETIC) 61PCY74 | AIME HAISLIPUNITED KIN |
| 4/13/2021 | SILDENAFIL CITRATE (REGULATOR) 65PCP02 | FITOLABECUADOR |
| 4/13/2021 | SILDENAFIL CITRATE (REGULATOR) 65PCP02 | FITOLABECUADOR |
| 4/13/2021 | SILDENAFIL CITRATE (REGULATOR) 65PCH02 | FITOLABECUADOR |
| 10/10/2017 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VAY99 | |
| 9/7/2017 | BETAMETHASONE DIPROPIONATE (GLUCOCORTICOID) 64LCJ06 | |
| 9/7/2017 | HYDROQUINONE (DEPIGMENTOR) 63VDJ02 | DREAM COSMETICSIVORY COAS |
| 9/7/2017 | HYDROQUINONE (DEPIGMENTOR) 63VBJ02 | |
| 9/7/2017 | HYDROQUINONE (DEPIGMENTOR) 63VBJ02 | DREAM COSMETICSIVORY COAS |
| 9/4/2017 | SALICYLIC ACID (KERATOLYTIC) 64XBJ06 | NP GANDOURIVORY COAS |
| 1/12/2017 | MEDROXYPROGESTERONE ACETATE (PROGESTIN) 65JIY21 | |
| 3/5/2015 | ANTI-PROTOZOAL, ANTI-LEISHMANIAL, ANTI-MALARIAL, N.E.C. 62LQT99 | |
| 2/26/2015 | ESTROGEN N.E.C. 64GCS99 | |
| 2/9/2015 | SILDENAFIL CITRATE (REGULATOR) 65PCT02 | Astral ScientificAUSTRALIA |
| 9/3/2014 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VCY99 | IpsenFRANCE |
Frequently Asked Questions
What is FDA violation code 2880?
2880 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) & 502(c), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 2880?
According to FDA Import Refusal data, there have been 51 import refusals issued for violation code 2880, affecting 45 unique firms.
When was the most recent refusal for violation 2880?
The most recent import refusal for violation 2880 was on October 25, 2024.
What products are commonly refused for violation 2880?
Products commonly refused under violation 2880 include: TIRZEPATIDE (ANTI-DIABETIC), SILDENAFIL CITRATE (REGULATOR), MISCELLANEOUS PATENT MEDICINES, ETC.. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 2880?
Violation code 2880 is based on 503(b)(4)(A) & 502(c), 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.