FDA import alert
Import Alert 66-66
APIs That Appear To Be Misbranded Under 502(f)(1) Because They Do Not Meet The Requirements For The Labeling Exemptions In 21 CFR 201.122
253
Red-list entries
0
Green-list entries
35
Countries
2023-12-26
Last change seen
What being on this list means
Firms on an import alert's Red List are subject to Detention Without Physical Examination (DWPE): FDA can detain their shipments at the border automatically, without sampling or inspecting them. The burden shifts to the importer to prove — typically with private laboratory analysis, shipment by shipment — that the goods are not violative. Removal from the list requires evidence that the underlying problem is resolved, usually including a track record of consecutive clean shipments and a petition to FDA. How removal works →
A Green List on a countrywide alert works the other way: it names the firms FDA has excluded from detention because they demonstrated compliance.
Red-list entries by country
+ 10 more countries
Firms on this red list
Showing 30 of 253 entries — search a specific firm on the free checker.
IDT Australia Ltd.
09/30/2009
Australia · Minocycline Hydrochloride (Tetracyclines)
Sandoz GmbH
09/30/2009
Austria · Kanamycin Sulfate (Aminoglycosides); Rifampin
Allied Signal
09/30/2009
Bahamas · Naproxen (Anti-Inflammatory), Active Pharm Ingred/Chems for Further Manuf
Pharmaceutical Fine Chemicals Ltd
09/30/2009
Bahamas · Doxazosin Mesylate (Anti-Hypertensive - Part II), Active Pharm Ingred/Chems for Further Manuf
ALCON-COUVREUR N.V.
09/30/2009
Belgium · Brinzolamide (Vasoconstrictor), Active Pharm Ingred/Chems for Further Manuf
Acros Organics B.V.B.A.
09/30/2009
Belgium · Oxytetracycline Hydrochloride (Tetracyclines), Active Pharm Ingred/Chems for Further Manuf
Pfizer Service Company
09/30/2009
Belgium · Doxazosin Mesylate (Anti-Hypertensive - Part II)
MERKABA CORP. LTD.
12/30/2016
Bulgaria · Herbals & Botanicals (not Teas), N.E.C.; Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Miscellaneous Patent Medicines, Etc.
Apotex Pharmachem Inc.
09/30/2009
Canada · Fluvoxamine Maleate (Anti-Depressant), Active Pharm Ingred/Chems for Further Manuf; Buspirone HCl (Tranquilizer), Active Pharm Ingred/Chems for Further Manuf
Choisy Laboratories Ltd
09/30/2009
Canada · Penicillin G, Natural, Active Pharm Ingred/Chems for Further Manuf; Penicillin V, Natural, Active Pharm Ingred/Chems for Further Manuf; Penicillin Natural, N.E.C., Active Pharm Ingred/Chems for Further Manuf
Delpharm Montreal Inc.
09/30/2009
Canada · Progesterone (Progestin), Active Pharm Ingred/Chems for Further Manuf
Forchem Canada Ltd
09/30/2009
Canada · Clindamycin Phosphate (Lincomycins), Active Pharm Ingred/Chems for Further Manuf
Formulex Canada Inc.
09/30/2009
Canada · Piroxicam (Anti-Inflammatory), Active Pharm Ingred/Chems for Further Manuf
Intergen Biomanufacturing Corp.
09/30/2009
Canada · Insulin Purified Beef (Anti-Diabetic), Active Pharm Ingred/Chems for Further Manuf
PF Soins de Sante SRI
09/30/2009
Canada · Immunosuppress N.E.C.
Patheon Inc.
09/30/2009
Canada · Night (Skin Care Preparations); Polyethylene Glycol 1500 (Pharmaceutic Necessity - Ointment Base)
Prinova Canada
09/30/2009
Canada · Tetracycline Hydrochloride (Tetracyclines)
RTP Pharma, Inc.
09/30/2009
Canada · Cyclosporine (Anti-Inflammatory), Active Pharm Ingred/Chems for Further Manuf
Wyeth-Ayerst Canada Inc
09/30/2009
Canada · Gonadorelin HCl (Gonad-Stimulating Principle), Active Pharm Ingred/Chems for Further Manuf
Anhui
09/30/2009
China · Heparin Sodium (Anti-Coagulant), Active Pharm Ingred/Chems for Further Manuf
Auspure Biotechnolgy Co., Ltd.
09/30/2009
China · Cholinergic N.E.C., Active Pharm Ingred/Chems for Further Manuf
CHENGDU SANHERB BIOSCIENCE CO.,LTD
07/28/2016
China · Tea Substitutes, N.E.C.; Vitamin, N.E.C.; L-Tryptophan (Protein)
CHINA NATIONAL COMPLETE PLANT IMP. AND EXP
09/30/2009
China · Prednisolone (Glucocorticoid), Active Pharm Ingred/Chems for Further Manuf
Chengdu Mechem Medicines & Chemicals Co.
09/30/2009
China · Oxytetracycline (Tetracyclines), Active Pharm Ingred/Chems for Further Manuf
China Export Bases Development Corp
09/30/2009
China · Gentamicin (Aminoglycosides), Active Pharm Ingred/Chems for Further Manuf; Streptomycin (Aminoglycosides), Active Pharm Ingred/Chems for Further Manuf; Oxytetracycline (Tetracyclines), Active Pharm Ingred/Chems for Further Manuf
China Hunam Walion Imp & Exp Corp
09/30/2009
China · Heparin Sodium (Anti-Coagulant), Active Pharm Ingred/Chems for Further Manuf
China Jiangsu Inernational Economic & Trad. Corp. Co.
09/30/2009
China · Trimethoprim (Anti-Bacterial), Active Pharm Ingred/Chems for Further Manuf
China Jiangsu Medicines & Health Products Import
09/30/2009
China · Testosterone (Androgen), Active Pharm Ingred/Chems for Further Manuf
China National Light Industrial Products Import & Export Cor
09/30/2009
China · Trimethoprim (Anti-Bacterial), Active Pharm Ingred/Chems for Further Manuf
Dandong Yichuang Pharmaceutical Co., Ltd.
09/30/2009
China · Promethazine HCl (Anti-Emetic/Nauseant), Active Pharm Ingred/Chems for Further Manuf
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