FDA recall D-0505-2024

Preferred Pharmaceuticals, Inc. · Class II · drug

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

Distribution

Product distributed to CA, FL, OK, KS and CT

Key facts

Status
Ongoing
Initiation date
2024-05-10
Report date
2024-05-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Anaheim, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0505-2024