Unit Dose Services, LLC – FDA Warning Letter, Oct 25, 2022

The FDA issued a Warning Letter to Peter Levasseur on October 17, 2022, regarding deficiencies in the drug listing for Lisinopril (NDC 50436-0353). The FDA's review of the firm's electronic Drug Registration and Listing System (eDRLS) submission revealed an incorrect carton label image.

Specifically, the uploaded label image for Lisinopril displayed "Pharbetol-Acetaminophen" as the active ingredient, which contradicts the electronic listing file (SPL) that correctly identifies Lisinopril. This constitutes a violation of Section 510(j)(1)(B)(i) of the FD&C Act and 21 CFR 207.49(a)(15)(ii), which require current and accurate labeling to be submitted.

The FDA had previously notified the firm of this deficiency on March 15, 2022, and subsequently removed the product's data from the Online NDC Directory on April 29, 2022, due to the continued non-compliance.

Failure to fulfill listing obligations under Section 510(j) is a prohibited act under Section 301(p) of the FD&C Act. Additionally, improper drug listing renders the product misbranded under Section 502(o), making its introduction into interstate commerce a prohibited act under Section 30