Reference Source

Dong Wha Pharm Co., Ltd. · 66-41 · KOREA (THE REPUBLIC OF)

For Dong Wha Pharm Co., Ltd. · 66-41 · KOREA (THE REPUBLIC OF), import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is KOREA (THE REPUBLIC OF); product is Pancold S Oral Liquid; product code is 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 U - - 99 Anti-Tussive/Cold N.E.C. | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs; date published is 08/19/2010; address is Lgseoulyeokbilding , Huam-Ro 98/19/F , Jung, Seoul KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

Firm
Dong Wha Pharm Co., Ltd. verified
Import alert
66-41
Import alert name
Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
Country
KOREA (THE REPUBLIC OF) verified
Address
Lgseoulyeokbilding , Huam-Ro 98/19/F , Jung, Seoul KOREA (THE REPUBLIC OF) verified
Date published
08/19/2010 verified
Product code
55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 U - - 99 Anti-Tussive/Cold N.E.C. | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs each item verified
Product
Pancold S Oral Liquid verified
FDA notes
"Pancold A" cough/cold drug product Marketed as: pain reliever-fever reducer, antihistamine, sputum suppressant, and nasal decongestant | "Pancold A" cough/cold drug product Marketed as: pain reliever-fever reducer, antihistamine, sputum suppressant, and nasal decongestant | "Pancold A" cough/cold drug product Marketed as: pain reliever-fever reducer, antihistamine, sputum suppressant, and nasal decongestant | Product labels made disease claims and the labeling information not meeting the OTC Monograph. | "Pancold A" cough/cold drug product Marketed as: pain reliever-fever reducer, antihistamine, sputum suppressant, and nasal decongestant | "Pancold A" cough/cold drug product Marketed as: pain reliever-fever reducer, antihistamine, sputum suppressant, and nasal decongestant | "Pancold A" cough/cold drug product Marketed as: pain reliever-fever reducer, antihistamine, sputum suppressant, and nasal decongestant | "Pancold A" cough/cold drug product Marketed as: pain reliever-fever reducer, antihistamine, sputum suppressant, and nasal decongestant | "Pancold A" cough/cold drug product Marketed as: pain reliever-fever reducer, antihistamine, sputum suppressant, and nasal decongestant each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Dong Wha Pharm Co., Ltd. Date Published : 08/19/2010 Lgseoulyeokbilding , Huam-Ro 98/19/F , Jung, Seoul KOREA (THE REPUBLIC OF) 55 - - - -- Pharm Necess & Ctnr For Drug/Bio Date Published: 08/19/2010 Notes: "Pancold A" cough/cold drug product Marketed as: pain reliever-fever reducer, antihistamine, sputum suppressant, and nasal decongestant 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs Date Published: 05/27/2022 60 - - - -- Human and Animal Drugs Date Published: 08/19/2010 Notes: "Pancold A" cough/cold drug product Marketed as: pain reliever-fever reducer, antihistamine, sputum suppressant, and nasal decongestant 61 - - - -- Human and Animal Drugs Date Published: 08/19/2010 Notes: "Pancold A" cough/cold drug product Marketed as: pain reliever-fever reducer, antihistamine, sputum suppressant, and nasal decongestant 62 U - - 99 Anti-Tussive/Cold N.E.C. Date Published: 12/15/2016 Desc: Pancold S Oral Liquid Notes: Product labels made disease claims and the labeling information not meeting the OTC Monograph. 62 - - - -- Human and Animal Drugs Date Published: 08/19/2010 Notes: "Pancold A" cough/cold drug product Marketed as: pain reliever-fever reducer, antihistamine, sputum suppressant, and nasal decongestant 63 - - - -- Human and Animal Drugs Date Published: 08/19/2010 Notes: "Pancold A" cough/cold drug product Marketed as: pain reliever-fever reducer, antihistamine, sputum suppressant, and nasal decongestant 64 - - - -- Human and Animal Drugs Date Published: 08/19/2010 Notes: "Pancold A" cough/cold drug product Marketed as: pain reliever-fever reducer, antihistamine, sputum suppressant, and nasal decongestant 65 - - - -- Human and Animal Drugs Date Published: 08/19/2010 Notes: "Pancold A" cough/cold drug product Marketed as: pain reliever-fever reducer, antihistamine, sputum suppressant, and nasal decongestant 66 - - - -- Human and Animal Drugs Date Published: 08/19/2010 Notes: "Pancold A" cough/cold drug product Marketed as: pain reliever-fever reducer, antihistamine, sputum suppressant, and nasal decongestant

accessdata.fda.gov, retrieved 2026-09-15

Source

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