Exact FDA event identifier

Event 90637

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

Event summary

Timeline bucket: July 20, 2022
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: AVKARE Inc.

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

Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-367-10, UPC 3 42291 36710 4

D-1329-2022

Recall number: D-1329-2022
Initiated: July 20, 2022
Classification: Class III
Status: Terminated
Recalling firm: AVKARE Inc.
Quantity: 8328 bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling: Label Error

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Label Error on Declared Strength

Code information

Lot #: 42581 Exp. 12/2024; 42484 Exp. 11/2024; 41204 Exp. 05/2024; 38723 Exp. 02/2023; 37623 Exp. 10/2022

Distribution pattern

Nationwide within the United States