Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03
Recall Number: D-0505-2024
Firm: Preferred Pharmaceuticals, Inc.
Classification: Class II
Status: Ongoing
Report Date: 20240529
Initiation Date: 20240510
Termination Date:
Reason for Recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Product Description
Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03