FDA WARNING_LETTER - NuCare Pharmaceuticals Inc - September 26, 2019

Record Details

This FDA Warning Letter, dated September 26, 2019 (WL #1280), addresses NuCare (Jasmine Contreras) for persistent non-compliance with drug listing requirements under Section 510 of the FD&C Act and 21 CFR Part 207.

The FDA manually reviewed over 200 of NuCare's listing files from August 2017 to the present, identifying numerous deficiencies. These issues were previously detailed in deficiency letters sent on August 10, 2017, August 14, 2017, and May 14, 2018. Despite some corrections, many incorrect listings remain unresolved, and recent submissions also contain errors.

Specific violations include: * **Incorrect carton label images:** Permethrin (showing Rosuvastatin Calcium), Bisoprolol Fumarate (showing Gemfibrozil), Doxycycline (showing Montelukast Sodium), Ear Wax Removal Drops (showing Hydrocortisone cream), Losartan Potassium (showing Amoxicillin). * **Mismatched strength in carton label and SPL:** Fluconazole (carton 150 mg, SPL 50 mg). * **Missing active ingredient names/strengths on carton label:** Dr. Sheffield Muscle Rub Cream (Menthol 10%, Methyl Salicylate 15%), Nystatin Cream (Nyst

Company: NuCare Pharmaceuticals Inc
Inspection Date: September 26, 2019
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Maria Rossana R. Cook

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ID · 4cf5529b-83bb-43b6-820d-9937ecf2f7e3

Violation Codes10

21 U.S.C. 331(a)FD&C Act 51021 CFR 20721 U.S.C. 360(b)21 U.S.C. 360(c)21 U.S.C. 360(d)21 U.S.C. 360(i)FD&C Act 510(j)21 U.S.C. 360(j)FD&C Act 510(j)(2)

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