Golden State Medical Supply Inc. is recalling Duloxetine (duloxetine delayed-release capsules, USP, 30mg) because testing identified N-nitroso-duloxetine, a nitrosamine drug substance related impurity, above the proposed interim limit. The recall affects 21,655 bottles of the 30-count size and 34,149 bottles of the 90-count size. Patients should contact their physician or healthcare provider to discuss alternative treatments before stopping their medication.
Nitrosamines are impurities that may increase the risk of cancer if individuals are exposed to them above acceptable levels over long periods of time. No adverse events have been reported to date in connection with this recall.
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Manufactured by Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain; Packaged by GSMS, Incorporated, Camarillo, CA.
Manufactured by Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain; Packaged by GSMS, Incorporated, Camarillo, CA.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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