Golden State Medical Supply Inc.: Drug Recall

Recall #D-0568-2024 · 05/13/2024

Class II: Risk

Recall Details

Recall Number
D-0568-2024
Classification
Class II
Product Type
Drug
Recalling Firm
Golden State Medical Supply Inc.
Status
Terminated
Date Initiated
05/13/2024
Location
Camarillo, CA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
21,655 (30 count bottle), 34,149 (90 count bottle)

Reason for Recall

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

Product Description

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.

Distribution Pattern

Nationwide in the U.S.

Other Recalls by Golden State Medical Supply Inc.

View all recalls by Golden State Medical Supply Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.