Drug Enforcement D-0505-2024

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

Status

Ongoing

Classification

Class II

Report Date

May 29, 2024

Termination Date

—

Product Information

Product description
Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03
Product quantity
66 bottles of 30 tablets
Reason for recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Product distributed to CA, FL, OK, KS and CT

Location & Firm

Recalling firm
Preferred Pharmaceuticals, Inc.
Address
1250 N Lakeview Ave Ste O

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0505-2024
Event ID
94648
Recall initiation date
May 10, 2024
Center classification date
May 21, 2024
Code info
Lot #: J2022G, Exp: 01/01/2025
More code info
—