Violation Code: 179
FDA Violation
Charge Code: AGR RX
Violation Details
- Violation Code (ASC ID)
- 179
- Charge Code
- AGR RX
- Description
- The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
- Legal Section
- 801(d)(1),(2); IMPORTATION RESTRICTED
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Bellegrove Medical Supply, Inc. | Redmond, UNITED STA | 90 |
| 2 | Ups Old Trk 1z4ar80504932220 | Bishekekbishekek, KYRGYZSTAN | 33 |
| 3 | ICU Medical, Inc. | Lake Forest, UNITED STA | 28 |
| 4 | Canada Drugs | Winnipeg, CANADA | 22 |
| 5 | Teva Pharmaceuticals USA, Inc | Parsippany, UNITED STA | 20 |
| 6 | Global Rx | Hillsborough, UNITED STA | 20 |
| 7 | Healthcare Alliance Inc | Woodbridge, CANADA | 19 |
| 8 | Abbott Laboratories | Abbott Park, UNITED STA | 19 |
| 9 | Eli Lilly & Company | Indianapolis, UNITED STA | 16 |
| 10 | Novo Nordisk Pharmaceutical Industries LP | Clayton, UNITED STA | 16 |
| 11 | Pfizer Inc. | New York, UNITED STA | 15 |
| 12 | B. Braun US Pharmaceutical Manufacturing, LLC | Irvine, UNITED STA | 14 |
| 13 | Excelsior Medical LLC | Neptune, UNITED STA | 14 |
| 14 | B Braun Medical Inc | Bethlehem, UNITED STA | 13 |
| 15 | Csc Pharmaceutical | Mumbai, INDIA | 13 |
| 16 | Baxter Healthcare Corporation | Deerfield, UNITED STA | 11 |
| 17 | Nan Drawie Lau | Markham, CANADA | 11 |
| 18 | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories | La Vergne, UNITED STA | 10 |
| 19 | Able Laboratories Inc. | S Plainfield, UNITED STA | 10 |
| 20 | Dover Apothecary | Port Dover, CANADA | 10 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 11/4/2025 | INSULIN DEGLUDEC 58HCP07 | |
| 11/4/2025 | APIXABAN (ANTI-COAGULANT) 61LCA44 | Bristol-Myers Squibb CompanyUNITED STA |
| 11/4/2025 | INSULIN DEGLUDEC 58HCP07 | |
| 11/4/2025 | INSULIN DEGLUDEC 58HCP07 | |
| 11/4/2025 | APIXABAN (ANTI-COAGULANT) 61LCA44 | Bristol-Myers Squibb CompanyUNITED STA |
| 11/4/2025 | ENDOCRINE-METABOLIC AGENT, NEC 58HCP99 | Eli Lilly & CompanyUNITED STA |
| 11/4/2025 | INSULIN DEGLUDEC 58HCP07 | |
| 11/4/2025 | INSULIN DEGLUDEC 58HCP07 | |
| 11/4/2025 | INSULIN DEGLUDEC 58HCP07 | |
| 11/4/2025 | INSULIN DEGLUDEC 58HCP07 | |
| 11/4/2025 | ENDOCRINE-METABOLIC AGENT, NEC 58HCP99 | Eli Lilly & CompanyUNITED STA |
| 11/4/2025 | INSULIN GLARGINE 58HCP09 | Eli Lilly & CompanyUNITED STA |
| 11/4/2025 | INSULIN GLARGINE 58HCP09 | Eli Lilly & CompanyUNITED STA |
| 11/4/2025 | INSULIN DEGLUDEC 58HCP07 | |
| 11/4/2025 | ENDOCRINE-METABOLIC AGENT, NEC 58HCP99 | Eli Lilly & CompanyUNITED STA |
Related Violations
Other violations under the same legal section: 801(d)(1),(2); IMPORTATION RESTRICTED
Frequently Asked Questions
What is FDA violation code 179?
179 is an FDA violation code that indicates: "The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.". This violation is based on 801(d)(1),(2); IMPORTATION RESTRICTED of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 179?
According to FDA Import Refusal data, there have been 1895 import refusals issued for violation code 179, affecting 965 unique firms.
When was the most recent refusal for violation 179?
The most recent import refusal for violation 179 was on November 4, 2025.
What products are commonly refused for violation 179?
Products commonly refused under violation 179 include: INSULIN DEGLUDEC, APIXABAN (ANTI-COAGULANT). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 179?
Violation code 179 is based on 801(d)(1),(2); IMPORTATION RESTRICTED 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.