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
Neomycin Sulfate Tablets, USP 500 mg , 100-count bottles, Rx only, Distributed by: TEVA PHARMACEUTICALS USA, INC North Wales, PA 19454, NDC 0093-1177-01
Foreign material or chemical contaminationreason.foreign_material_chemical_contamination · v1.0.0
foreign matter
Manufacturing or process controlreason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
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Reason for recall
CGMP Deviations: A foreign matter identified as teflon was found in the Active Pharmaceutical Ingredient (API) used in the manufacture of Neomycin Sulfate Tablets, USP 500 mg.
Code information
Lot #: 3007830, 3007746, 3007829, Exp. Date 10/2024