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FDA Warning Letter Explorer
FDA warning letter · Drugs

Unit Dose Services, LLC

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 review of the listing submission for Lisinopril NDC 50436-0353 revealed that the label image uploaded into the FDA’s electronic Drug Registration and Listing System (eDRLS) does not match your product’s label. The active ingredients included in the label image do not accurately reflect the active ingredient included in the electronic listing file (SPL). Specifically, while the electronic listing file refers to Lisinopril, the carton label image included in the same listing submission refers to Pharbetol-Acetaminophen.

Citations in the original letter

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

  • 21 CFR 207.49
  • 21 CFR 207.57(b)(2)