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.
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
Nicotine Gum, Nicotine Polacrilex Gum USP, 2 mg (nicotine), 110-count pieces per carton, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-3328-3.
Labeling or packagingreason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Labeling: Incorrect or Missing Package Insert: The package insert included in the finished product is for the Canadian market and is not part of the current approved drug labeling.
Code information
Lot # WJ04186, exp. date 01/23
Distribution pattern
Recalled product was distributed to one retailer type in NY and MD who may have further distributed the product throughout the United States.
