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Drug FDA Class II Terminated cGMP deviation

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.

Golden State Medical Supply Inc. Published Jul 3, 2024

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 55/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Golden State Medical Supply Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Hazards

N-nitroso-duloxetine · primary

Affected products (1)

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.

DULOXETINE · 21,655 (30 count bottle), 34,149 (90 count bottle)

NDC: 60429-164, 60429-165, 60429-166, 60429-164-60, 60429-165-30, 60429-165-90, 60429-166-30, 60429-166-10
Code info: Lot: a) GS045371, Exp: 01/31/2025; b) GS045910, Exp. 01/31/2025

Affected areas

Nationwide

Timeline

  1. Initiated
    May 13, 2024
  2. Published
    Jul 3, 2024
  3. Terminated
    Mar 20, 2025
Recall number
D-0568-2024
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.