Reference Source

Mcneil Products · 66-41 · UNITED KINGDOM

For Mcneil Products · 66-41 · UNITED KINGDOM, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is UNITED KINGDOM; product is Nicorette Nasal Spray; product code is 66 B - - 44 Nicotine Delivery System; date published is 11/03/2014; address is Maidenhead , Berkshireberkshire, UNITED KINGDOM, verified against its source on 2026-09-16.

Firm
Mcneil Products verified
Import alert
66-41
Import alert name
Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
Country
UNITED KINGDOM verified
Address
Maidenhead , Berkshireberkshire, UNITED KINGDOM verified
Date published
11/03/2014 verified
Product code
66 B - - 44 Nicotine Delivery System verified
Product
Nicorette Nasal Spray verified
FDA notes
The referenced product appears to be an unapproved new drug as the product labeling lists claims such as; 'Nicorette Nasal Spray is for the rapid relief of nicotine withdrawal symptoms as an aid to giving up smoking;' 'To relieve cravings and nicotine withdrawal symptoms;' and 'You are more likely to quit smoking when using this product with help from your pharmacist; doctor; a trained counsellor or a support programme'. verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Mcneil Products Date Published : 11/03/2014 Maidenhead , Berkshireberkshire, UNITED KINGDOM 66 B - - 44 Nicotine Delivery System Date Published: 11/03/2014 Desc: Nicorette Nasal Spray Notes: The referenced product appears to be an unapproved new drug as the product labeling lists claims such as; 'Nicorette Nasal Spray is for the rapid relief of nicotine withdrawal symptoms as an aid to giving up smoking;' 'To relieve cravings and nicotine withdrawal symptoms;' and 'You are more likely to quit smoking when using this product with help from your pharmacist; doctor; a trained counsellor or a support programme'.

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

Source

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