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 3
Soothe & Cool Protect Moisture Guard Skin Protectant (petrolatum 59%),3.5 oz tubes, Manufactured in USA for: Medline Industries, Inc., Mundelein, IL 60060 USA NDC 53329-303-22
Manufacturing or process controlreason.manufacturing_process_control · v1.0.0
GMP Deviations
Potency or specification failurereason.potency_specification_failure · v1.0.0
Out of specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
Code information
Lot #: 50G17, Exp. 5/2019; 76J17, Exp. 7/2019
Distribution pattern
Nationwide within the United States
drug · product 2 of 3
Hydrocortisone Cream 1% MS Anti itch Cream with Intensive Healing 2 oz tubes, Distributed by: Walgreen Co. 200 Wilmot Rd. Deerfield, IL 60015, NDC 0363-0237-03
Manufacturing or process controlreason.manufacturing_process_control · v1.0.0
GMP Deviations
Potency or specification failurereason.potency_specification_failure · v1.0.0
Out of specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
Code information
Lot #: 36G17, 47G17, Exp. 5/2019; 84J17, Exp. 7/2019
Distribution pattern
Nationwide within the United States
drug · product 3 of 3
Medline Remedy Essential Barrier Skin Protectant Ointment (petrolatum 59%) packaged in a) 2 oz tubes (NDC 53329-302-14) and b) 6 oz tubes (NDC 53329-302-41), Medline Industries Inc., Manufactured for Medline Industries Inc., Mundelien, IL 60060.
