Class II Recall

Preferred Pharmaceuticals, Inc.

Product
Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03
Reason
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Classification
Class II
Status
Ongoing
Lot
Lot #: J2022G, Exp: 01/01/2025
Date
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