Direct Rx: Drug Recall

Recall #D-0829-2021 · 09/14/2021

Class II: Risk

Recall Details

Recall Number: D-0829-2021
Classification: Class II
Product Type: Drug
Recalling Firm: Direct Rx
Status: Terminated
Date Initiated: 09/14/2021
Location: Dawsonville, GA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2 bottles

Reason for Recall

CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory.

Product Description

Zonisamide 100 mg Capsules, 30-count bottles, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-0775-30

Distribution Pattern

FL only

Other Recalls by Direct Rx

Class II: Risk 03/07/2025

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class II: Risk 03/07/2025

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class II: Risk 01/31/2025

Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Class II: Risk 08/09/2024

Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
Class II: Risk 03/22/2023

CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.

View all recalls by Direct Rx →

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.