Breckenridge Pharmaceutical, Inc. — Class II: Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-
Breckenridge Pharmaceutical, Inc. has initiated a Class II recall for specific lots of Duloxetine Delayed-Release Capsules, 60mg, due to CGMP deviations involving the presence of N-nitroso-duloxetine impurity above the FDA's recommended interim limit.
This affects Breckenridge Pharmaceutical, Inc., its manufacturer Towa Pharmaceutical Europe, S.L., and entities involved in the distribution and clinical management of Duloxetine Delayed-Release Capsules (60mg).
The presence of nitrosamine impurities above interim limits indicates potential deficiencies in manufacturing controls or stability monitoring. This Class II classification suggests that while the health hazard is not immediate or life-threatening, it represents a significant regulatory non-compliance that necessitates corrective action and supply chain intervention.
Regulatory and QA departments should verify if affected lots are in inventory, secure them in a quarantined area, and prepare for reconciliation and reporting as required by the ongoing recall status. Manufacturing and quality teams may need to review impurity testing protocols to ensure alignment with current interim limits.
Class II. Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. Product: 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.. Firm: Breckenridge Pharmaceutical, Inc. (Berkeley Heights NJ United States). Status: Ongoing.
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