Reference Source

Pharmaster + · 66-41 · FRANCE

For Pharmaster +, import alert is 66-41; country is FRANCE; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; product is Simply Saline Nasal Pump Mist; product code is 77 K - - CO Inhaler, Nasal; date published is 06/05/2020; address is Zone Industrielle de Erstein Krafft , Route de Krafft , Erstein, Grand Est FRANCE, verified against its source on 2026-10-01.

Firm
Pharmaster + verified
Import alert
66-41
Import alert name
Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
Country
FRANCE verified
Address
Zone Industrielle de Erstein Krafft , Route de Krafft , Erstein, Grand Est FRANCE verified
Date published
06/05/2020 verified
Product code
77 K - - CO Inhaler, Nasal verified
Product
Simply Saline Nasal Pump Mist verified
FDA notes
This product appears to be an unapproved new drug as the product label includes claims such as: "Comforting mist flushes allergens to help clear congestion while long-lasting moisture helps soothe irritated nasal and sinus passages." verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Pharmaster + Date Published : 06/05/2020 Zone Industrielle de Erstein Krafft , Route de Krafft , Erstein, Grand Est FRANCE

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

Where each value comes from

The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.

Product code, Product and FDA notes

77 K - - CO Inhaler, Nasal Date Published: 06/05/2020 Desc: Simply Saline Nasal Pump Mist Notes: This product appears to be an unapproved new drug as the product label includes claims such as: "Comforting mist flushes allergens to help clear congestion while long-lasting moisture helps soothe irritated nasal and sinus passages."

— all from accessdata.fda.gov, retrieved 2026-09-15

Source

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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