Reference Source

Guangdong T&K Pharmaceutical Factory Co., Ltd. · 66-41 · CHINA

For Guangdong T&K Pharmaceutical Factory Co., Ltd. · 66-41 · CHINA, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is CHINA; product code is 60 L - - 99 Analgesic, N.E.C; date published is 09/30/2009; address is 48 Pujianglu , Longhu , Shantou, Guangdong CHINA, verified against its source on 2026-09-16.

Firm
Guangdong T&K Pharmaceutical Factory Co., Ltd. verified
Import alert
66-41
Import alert name
Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
Country
CHINA verified
Address
48 Pujianglu , Longhu , Shantou, Guangdong CHINA verified
Date published
09/30/2009 verified
Product code
60 L - - 99 Analgesic, N.E.C. verified
FDA notes
9/3/2008. PainNot Patch. Claims of "Pain Relieving Patch...for temporary relief of minor aches and pains...works in 10 minutes to relieve pain..." and "relieves pain from arthritus; back; bursitus; carpal tunnel; tendonitis; sprains; strains; and more..." were during the review of labeling for the product and the internet website for the intitial distributor; Suarez Corporation. Also; review of the formulation found that it did not match the Tentative Final Monogrpah for OTC External Analgesics. verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Guangdong T&K Pharmaceutical Factory Co., Ltd. Date Published : 09/30/2009 48 Pujianglu , Longhu , Shantou, Guangdong CHINA 60 L - - 99 Analgesic, N.E.C. Date Published: 09/30/2009 Notes: 9/3/2008. PainNot Patch. Claims of "Pain Relieving Patch...for temporary relief of minor aches and pains...works in 10 minutes to relieve pain..." and "relieves pain from arthritus; back; bursitus; carpal tunnel; tendonitis; sprains; strains; and more..." were during the review of labeling for the product and the internet website for the intitial distributor; Suarez Corporation. Also; review of the formulation found that it did not match the Tentative Final Monogrpah for OTC External Analgesics.

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

Source

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