Drug recall D-0505-2024

Class II Ongoing reported May 29, 2024

Product

Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03

Reason for recall

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Lots and codes

Lot #: J2022G, Exp: 01/01/2025

Recall details

Recalling firm
Preferred Pharmaceuticals, Inc., Anaheim, CA
Quantity
66 bottles of 30 tablets
Distribution
Product distributed to CA, FL, OK, KS and CT
Type
Voluntary: Firm initiated
Recall initiated
May 10, 2024