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FDA Warning Letter Explorer
FDA warning letter · Drugs

Grimann S.A. de C.V.

Issued · Posted by FDA

FDA published a close-out letter on Jun 24, 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 active ingredients described on the carton label are dextromethorphan and guaifenesin, while the active ingredient included in the electronic listing file is propylene glycol.

Passage 2

the carton label refers to a syrup containing dextromethorphan and guaifenesin, but the Drug Facts section of the labeling includes loratadine tablets indicated for allergic rhinitis, while the listing SPL refers to propylene glycol as active ingredient.

Passage 3

the carton label image includes the size as 118 ml, while the electronic listing file includes the size as 1 U in 1 bottle.

Citations in the original letter

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

  • 21 CFR 207.49(a)(4)
  • 21 CFR 207.49
  • 21 CFR 207.57(b)(2)
  • 21 CFR 207