May 2024 FDA Recall Drug by Preferred Pharmaceuticals, Inc.
D-0505-2024 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Preferred Pharmaceuticals, Inc. on May 10, 2024 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Product distributed to CA, FL, OK, KS and CT and the recall is currently ongoing.

Recall Number: D-0505-2024

Reason for Recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Initiated
05-10-2024
Reported
05-29-2024
Quantity
66 bottles of 30 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
94648
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.
Preferred 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product distributed to CA, FL, OK, KS and CT
Product Description About Product Description
Full technical description of the product.
Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03

Batch or Lot Expiration Information

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