December 2024 FDA Recall Drug by Pd-rx Pharmaceuticals, Inc.
D-0163-2025 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Pd-rx Pharmaceuticals, Inc. on December 4, 2024 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Distributed within US: FL, MS, WI and the recall is currently terminated.

Recall Number: D-0163-2025

Reason for Recall
CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit
Initiated
12-04-2024
Reported
01-01-2025
Quantity
70, 90-count bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
95922
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
PD-Rx Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed within US: FL, MS, WI
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2025
Product Description About Product Description
Full technical description of the product.
DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90

Batch or Lot Expiration Information

Lot# I24E77, A24E49, Exp Date: 04/30/25; J23C50, J23C97, L23B39, L23E98, Exp Date: 01/31/2025