||88749 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
||D-0829-2021 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
||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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
||FL only What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
||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
|Reason For Recall
||CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory. What is the Reason for Recall?
Information describing how the product is defective.
||2 bottles Product Quantity
The amount of product subject to recall.
||Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
|Recall Initiation Date
||09-14-2021 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall.
||10-22-2021 What is the Date Terminated?
The date that FDA terminated the recall.
|Initial Firm Notification
||Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall.
||Lot #: 17JU2118 Exp. 5/31/23 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
||Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.