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Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, a) 30 capsules bottles, NDC 60429-165-30...

FDA Recall #D-0568-2024 — Class II — May 13, 2024

Recall #D-0568-2024 Date: May 13, 2024 Classification: Class II Status: Terminated

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.

Reason for Recall

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

Recalling Firm

Golden State Medical Supply Inc. — Camarillo, CA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

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

Distribution

Nationwide in the U.S.

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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