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
Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial. Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618 USA. NDC: 0703-0018-01
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: Silicone oil
Code information
Lot #: 560053F, Exp. 01AUG2017
Distribution pattern
Nationwide in the USA
drug · product 2 of 3
Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial per Carton, 100 vials per case. Hospira, Inc., Lake Forest, IL 60045 USA, NDC: 0409-2634-50
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: Silicone oil
Code information
Lot #: 56260DD, Exp. 01AUG2017
Distribution pattern
Nationwide in the USA
drug · product 3 of 3
Hydromorphone Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 5 mL Single Dose Vial.(10 vials per carton NDC 0703-0113-01) and 180 vials per case (NDC 0703-0113-03) Mfd By: Hospira, Inc., Lake Forest, IL 60045 USA, Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618 USA.
