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
Amiodarone Hydrochloride Injection, USP, 150 mg per 3 mL (50 mg / mL), 3 mL Single Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-180-03
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
Crystallization: Presence of visible particulate matter.
Code information
Lot# CAH180009, exp. date Feb 2020
Distribution pattern
Distributed Nationwide in the US
drug · product 2 of 3
Amiodarone Hydrochloride Injection, USP, 450 mg per 9 mL (50 mg / mL), 9 mL Single Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-181-09
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
Crystallization: Presence of visible particulate matter.
Code information
Lot# CAH180001, exp. date Jan 2020; CAH180003, exp. date Feb 2020; CAH180011, CAH180012, exp. date Jun 2020
Distribution pattern
Distributed Nationwide in the US
drug · product 3 of 3
Amiodarone Hydrochloride Injection, USP, 900 mg per 18 mL (50 mg / mL), 18 mL Multiple Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-182-18
