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 4
fas.TRACT Coagulative Hemostatic Gel, 10% Ferric Sulfate Kit, Rx Only, (3) 3cc Preloaded Syringes/ (50) Scrub Tips. Distributed by: Benco Dental, 295 Center Point Blvd., Pittston, PA 18640. NDC: 14060-01105
Manufacturing or process controlreason.manufacturing_process_control · v1.0.0
cGMP violations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
cGMP violations noted during the firm's most recent inspection.
Code information
Lot # 170831, EXP 8/31/2019; 180704, EXP 7/04/2020
Distribution pattern
Nationwide in the US
drug · product 2 of 4
SHEER DesenZ Desensitizing Treatment, Rx Only, Potassium Nitrate 12mg per film. CAO GROUP, INC, 4628 West Skyhawk Drive West Jordan, UT 84084. UPC: 8 72320 00072 1 NDC 1406000304
Manufacturing or process controlreason.manufacturing_process_control · v1.0.0
cGMP violations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
cGMP violations noted during the firm's most recent inspection.
Code information
Lot # 170626, EXP 6/26/2019; and 180131, EXP 01/31/2020
Distribution pattern
Nationwide in the US
drug · product 3 of 4
BeeGentle Honey Flavored Topical Anesthetic, Active ingredient Benzocaine 20%. Packaged in: a) Introductory Kit. Net Qty 3-3cc preloaded syringes. . NDC# 1406000203 UPC 8 72320 00074 5 b) Bulk Kit Net Qty 30mL, NDC# 1406000202, UPC 8 72320 00076 9. Manufactured by CAO (China) Medical Equipment Co. Ltd. for CAO Group, Inc. 4628 West Skyhawk Drive, West Jordan, UT 84084