# FDA recall D-0568-2024

> **Golden State Medical Supply Inc.** · Class II · drug recall initiated 2024-05-13.

## Product

Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, a) 30 capsules bottles, NDC 60429-165-30; b) 90 capsules bottles, NDC 60429-165-90, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Packaged by GSMS, Incorporated, Camarillo, CA 93012.

## Reason for recall

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.

## Distribution

Nationwide in the U.S.

## Key facts

- **Recall number:** D-0568-2024
- **Recalling firm:** Golden State Medical Supply Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2024-05-13
- **Report date:** 2024-07-03
- **Termination date:** 2025-03-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Camarillo, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0568-2024

## Citation

> AI Analytics. FDA recall D-0568-2024. Retrieved 2026-07-01 from https://api.ai-analytics.org/recall/D-0568-2024. Source: US FDA. Licensed CC0.

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