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Recall

Breckenridge Pharmaceutical, Inc.: Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Recall

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit Product details: Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely Heights, NJ 07922, NDC 51991-748-90.

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Agency
FDA
Record ID
D-0522-2026
Canonical
https://claimwatch-mvp.vercel.app/item/breckenridge-pharmaceutical-inc-duloxetine-delayed-release-capsules-usp-60mg-rx-only-90-co/

What happened?

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit Product details: Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely Heights, NJ 07922, NDC 51991-748-90.

Who may be affected?

Nationwide in the USA

What should consumers do?

Affected quantity: 165,761 90-count bottles

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