September 2021 FDA Recall Drug by Direct Rx
D-0829-2021 - CGMP deviations

This Class II drug recall was voluntarily initiated by Direct Rx on September 14, 2021 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in FL only and the recall is currently terminated.

Recall Number: D-0829-2021

Reason for Recall
CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Initiated
09-14-2021
Reported
09-29-2021
Quantity
2 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88749
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Direct Rx
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.
FL only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-22-2021
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# : 17JU2118 Exp. 5/31/23