Healthnational✓ verified · 95%
Drug recall: Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsules (51991-748-10), Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. — Breckenridge Pharmaceutical, Inc.
- When
- · day precision
- Where
- Berkeley Heights, NJ, US
- Category
- recall · drug_recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
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Correlated events
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