FDA WARNING_LETTER - Century Pharmaceuticals, Inc. - November 26, 2024

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On November 15, 2024, the FDA issued a Warning Letter to Mr. Patel regarding "BLT 1-2-3 Cream," sold on www.centurapharma.com and centurabltcream.com. The FDA's review in April 2024 found the product to be an unapproved new drug and misbranded.

The "BLT 1-2-3 Cream" is an unapproved new drug under sections 505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and 331(d)). It is also misbranded under section 502(ee) (21 U.S.C. 352(ee)), with introduction into interstate commerce prohibited by section 301(a) (21 U.S.C. 331(a)).

The product is intended as an external analgesic, containing benzocaine 20%, lidocaine HCl 4%, and tetracaine 2%. The FDA has safety concerns due to its intended use before cosmetic procedures, which could increase absorption and lead to serious injury, especially without professional supervision.

Violations include: 1. **Unapproved New Drug:** The product is a "new drug" as defined by section 201(p) of

Company: Century Pharmaceuticals, Inc.
Inspection Date: November 26, 2024
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Tina Smith (Director)

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ID · c4cbf7ef-053c-4101-8072-b205fd3f8420

Violation Codes7

21.U.S.C. 355(a)21 U.S.C. 331(d)21 U.S.C. 352(ee)21 U.S.C. 321(g)(1)(B)21 U.S.C. 321(g)(1)(C)21 U.S.C. 321(p)21 U.S.C. 331(a)

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