Preferred Pharmaceuticals, Inc.: Drug Recall

Recall #D-0505-2024 · 05/10/2024

Class II: Risk

Recall Details

Recall Number: D-0505-2024
Classification: Class II
Product Type: Drug
Recalling Firm: Preferred Pharmaceuticals, Inc.
Status: Ongoing
Date Initiated: 05/10/2024
Location: Anaheim, CA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 66 bottles of 30 tablets

Reason for Recall

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

Product Description

Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03

Distribution Pattern

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

Other Recalls by Preferred Pharmaceuticals, Inc.

Class II: Risk 11/17/2025

Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Class II: Risk 04/18/2025

cGMP Deviations
Class II: Risk 08/08/2024

Failed Impurities/Degradation Specifications - at 18-month Stability testing
Class II: Risk 06/26/2023

Failed Stability Specifications
Class II: Risk 03/27/2023

CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.

View all recalls by Preferred Pharmaceuticals, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.