← FDA ENFORCEMENT
D-0568-2024Class II

Golden State Medical Supply Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Golden State Medical Supply Inc.
Product type
Drug
Status
Terminated
Report date
2024-07-03
Distribution
Nationwide in the U.S.
Firm state
CA
Product quantity
21,655 (30 count bottle), 34,149 (90 count bottle)
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
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.

Code / lot info

Lot: a) GS045371, Exp: 01/31/2025; b) GS045910, Exp. 01/31/2025

Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →