# FDA enforcement report D-1178-2023

> FDA's dated enforcement report D-1178-2023 lists Class III and source status Terminated for Tolmar, Inc. PeptideScanner connects the report to reviewed application NDA021379 through exact openFDA application-number annotations.

- Evidence object: `story:fda-enforcement-d-1178-2023:v1`
- Evidence domain: Safety
- Date in source: 2023-10-04
- Source checked: 2026-08-25
- Published by PeptideScanner: 2026-08-25
- Story landing page: https://peptidescanner.com/stories/fda-enforcement-d-1178-2023/
- JSON record: https://peptidescanner.com/evidence/v1/objects/fda-enforcement-d-1178-2023-v1.json
- Content SHA-256: `8d1bd706a720e7a3fb563b58e3aeb9d225118ccea076a7c8d38960b6676920a3`

## Claims and source pins

### Headline

FDA enforcement report D-1178-2023 ([`fda-enforcement-d-1178-2023-62ec8c01e26e`](#source-fda-enforcement-d-1178-2023-62ec8c01e26e))

### Summary

FDA's dated enforcement report D-1178-2023 lists Class III and source status Terminated for Tolmar, Inc. PeptideScanner connects the report to reviewed application NDA021379 through exact openFDA application-number annotations. ([`fda-enforcement-d-1178-2023-62ec8c01e26e`](#source-fda-enforcement-d-1178-2023-62ec8c01e26e))

### Paragraph 1

FDA's dated enforcement report D-1178-2023 lists Class III and source status Terminated for Tolmar, Inc. PeptideScanner connects the report to reviewed application NDA021379 through exact openFDA application-number annotations. ([`fda-enforcement-d-1178-2023-62ec8c01e26e`](#source-fda-enforcement-d-1178-2023-62ec8c01e26e))

### Paragraph 2

FDA's source-reported reason is: Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product. ([`fda-enforcement-d-1178-2023-62ec8c01e26e`](#source-fda-enforcement-d-1178-2023-62ec8c01e26e))

### Paragraph 3

This PeptideScanner lane is a bounded, dated FDA enforcement-report snapshot connected through an exact openFDA application-number annotation. It is not a medical alert or complete recall-lifecycle tracker, does not establish current product or recall status, does not identify affected lots, and does not provide medical guidance. ([`fda-enforcement-d-1178-2023-62ec8c01e26e`](#source-fda-enforcement-d-1178-2023-62ec8c01e26e))

## Sources

<a id="source-fda-enforcement-d-1178-2023-62ec8c01e26e"></a>
- **FDA enforcement report D-1178-2023 · Class III · report date 2023-10-04 · source status Terminated** — FDA enforcement reports via openFDA; class A. [Open source](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-1178-2023%22&limit=1) (`fda-enforcement-d-1178-2023-62ec8c01e26e`)

## Correction lineage

No correction is recorded for this version.

## Reporting boundaries and unknowns

PeptideScanner reports the cited safety or enforcement record. It is not an individualized risk assessment or medical recommendation.

- Sources outside the selected public PeptideScanner bundle may exist and are not represented by this object.
- This object does not determine whether cited records agree, corroborate one another, or establish scientific truth.
- This object does not determine safety, efficacy, causality, or suitability for any person.

Methodology: https://peptidescanner.com/methodology/
Medical disclaimer: https://peptidescanner.com/medical-disclaimer/

## Suggested citation

PeptideScanner. "FDA enforcement report D-1178-2023." Version 1, published 2026-08-25. https://peptidescanner.com/evidence/v1/objects/fda-enforcement-d-1178-2023-v1.json SHA-256: 8d1bd706a720e7a3fb563b58e3aeb9d225118ccea076a7c8d38960b6676920a3.