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.
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drug · product 1 of 1
Famotidine Injection 20 mg, Rx Only, GALAXY Single Dose Container, Code 2G3424, Sterile Nonpyrogenic, 50 mL Iso-osmotic, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-5197-41.
Foreign material or chemical contaminationreason.foreign_material_chemical_contamination · v1.0.0
Particulate Matter
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Presence of Particulate Matter: Baxter Healthcare Corporation has received a complaint reporting the presence of particulate matter identified as plastic/rubber in famotidine Injection premixed containers.
