December 2024 FDA Recall Drug by Remedyrepack Inc.
D-0165-2025 - CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.

This Class II drug recall was voluntarily initiated by Remedyrepack Inc. on December 2, 2024 for the product Drug. The FDA reported the reason for recall as cgmp deviations; presence of n-nitroso-duloxetine impurity above recommended interim limit.. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0165-2025

Reason for Recall
CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
Initiated
12-02-2024
Reported
01-01-2025
Quantity
a) 1,564 cards, b) 799 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
95900
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
RemedyRepack 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the US
Product Description About Product Description
Full technical description of the product.
Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged by: RemedyRepack Inc., Indiana, PA

Batch or Lot Expiration Information

Lot# a) NDC 70518-0937-04
Lot# J0786744-061724, Exp. 06/30/2025 b) NDC 70518-0937-03
Lot# B3002625-060524, Exp. 10/31/2025