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FDA Warning Letter Explorer
FDA warning letter · Drugs

RiteAid Corporation

Issued · Posted by FDA

FDA published a close-out letter on Dec 27, 2022. 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 names of the active ingredients listed in the electronic listing file for Mucus Relief DM, NDC 11822-7224, do not match the names of the active ingredients found on the copy of the labeling provided with the listing submission. Specifically, the names of active ingredients found in the electronic copy include dextromethorphan hydrobromide, guaifenesin, and phenylephrine hcl, while the labeling only includes dextromethorphan hydrobromide and guaifenesin.

Citations in the original letter

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

  • 21 CFR 207