Exact FDA event identifier

Event 88749

1 recalled-product record grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: September 14, 2021
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Direct Rx

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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

D-0829-2021

Recall number: D-0829-2021
Initiated: September 14, 2021
Classification: Class II
Status: Terminated
Recalling firm: Direct Rx
Quantity: 2 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

FL only