Preferred Pharmaceuticals, Inc.: Drug Recall

Recall #D-0518-2023 · 03/23/2023

Class II: Risk

Recall Details

Recall Number: D-0518-2023
Classification: Class II
Product Type: Drug
Recalling Firm: Preferred Pharmaceuticals, Inc.
Status: Ongoing
Date Initiated: 03/23/2023
Location: Anaheim, CA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: a) 266 Bottles, b) not reported, c) 216 Bottles

Reason for Recall

cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Product Description

Montelukast Sodium Tablets, USP, 10 mg, packaged in: a) 30-count bottle (NDC 68788-9438-3); b) 60-count bottle (NDC 68788-9438-6); c) 90-count bottle (NDC 68788-9438-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703.

Distribution Pattern

USA Nationwide

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 05/10/2024

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II: Risk 06/26/2023

Failed Stability Specifications

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.