Preferred Pharmaceuticals, Inc.: Drug Recall

Recall #D-0894-2023 · 06/26/2023

Class II: Risk

Recall Details

Recall Number: D-0894-2023
Classification: Class II
Product Type: Drug
Recalling Firm: Preferred Pharmaceuticals, Inc.
Status: Ongoing
Date Initiated: 06/26/2023
Location: Anaheim, CA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 541 Bottles

Reason for Recall

Failed Stability Specifications

Product Description

Tizanidine Hydrochloride Tablet 4mg, packaged in a) 20 count-bottles (NDC 68788-7781-2), b)30-count bottles (NDC: 68788-7781-3), c) 60-count bottles, (NDC: 68788-7781-6), d) 90-count bottles (NDC: 68788-7781-9), e) 120-count bottles (NDC: 68788-7781-8), Rx only, Mfg: Dr. Reddy's Laboratories Limited.

Distribution Pattern

Nationwide within the United States

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 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.