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 2
HCG (Lyophilized) Stock # 21714, 5000 IUnits-5 mL vial, Compounded by NuVision Pharmacy Dallas, TX 75244
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Lack of Assurance of Sterility: The recall is being initiated due to a lack of sterility assurance and concerns associated with the quality control processes identified during an FDA inspection.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Lack of Assurance of Sterility: The recall is being initiated due to a lack of sterility assurance and concerns associated with the quality control processes identified during an FDA inspection.
