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FDA Warning Letter Explorer
FDA warning letter · Drugs

RPK Pharmaceuticals Inc.

Issued · Posted by FDA

FDA published a close-out letter on Jun 7, 2021. The passages below are from the original warning letter.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

the label image you provided to FDA states “triamcinolone 0.1 % ointment,” whereas the product name included in the drug listing submission is “clotrimazole and betamethasone dipropionate cream.”

Citations in the original letter

As cited in this historical letter, not a statement of current regulatory requirements.

  • 21 CFR 207