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 8
PHENYLephrine HCl, 50 mg added to 250 mL 0.9% Sodium Chloride Injection USP (200 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-171-50
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: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Code information
Lot #: 14310039S, Exp 11/06/14; 14318006S, Exp 11/17/14; 14321060S, Exp11/07/14
Distribution pattern
Nationwide
drug · product 2 of 8
PHENYLephrine HCl, 40 mg added to 250 mL 0.9% Sodium Chloride Injection USP (160 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-169-50
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: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Code information
Lot #: 14309095S, Exp 02/03/15; 14311008S, Exp 02/05/15
Distribution pattern
Nationwide
drug · product 3 of 8
Bupivacaine HCl 0.0625%, 250 mL total volume in a 250 mL LifeCare Bag in Sodium chloride 0.9%, Epidural Use Only, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 36141, NDC# 61553-197-50
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: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Morphine Sulfate, 1 mg per mL (250 mg per 250 mL), 250 mL total volume in a 250 mL LifeCare bag in Sodium Chloride 0.9%, IV Use Only, Rx only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 36141, NDC# 61553-181-50
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: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Fentanyl Citrate, 5 mcg per mL (1,250 mcg per 250 mL), 250 mL total volume in a 250 mL LifeCare bag in Sodium Chloride 0.9%, IV Use Only, Rx only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 36141, NDC# 61553-107-50
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: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
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: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
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: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Code information
Lot #: 14317035S, Exp 02/11/15
Distribution pattern
Nationwide
drug · product 8 of 8
PHENYLephrine HCl, 10 mg added to 250 mL 0.9% Sodium Chloride Injection USP (40 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-149-50
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: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Code information
Lot #: 14308086S, Exp 02/02/15; 14309051S, Exp 02/03/15